Manager, Medical Affairs Resume Samples

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M Wyman

Michel

Wyman

95735 Douglas Key

Houston

+1 (555) 839 8607

95735 Douglas Key

Houston

Phone

p +1 (555) 839 8607

Experience Experience

Dallas, TX

Manager, Medical Affairs

Dallas, TX

Dietrich, Smith and McDermott

Dallas, TX

Manager, Medical Affairs

Develops and maintains a network of external experts (KOLs) and corresponding engagement plans (at local level)
Provides local Input to TA specific global medical affairs plans
Develop Standard and Custom Response Letters for use by Medical Information vendor and maintain a database of current and archived letters
Participate in post-market research initiatives including development of safety surveillance registry protocols, study database analyses, and reporting
Provides expert clinical and technical product knowledge in response to clinical/medical inquiries from external and internal customers
Develop affiliate medical affairs plans
Provide medical input into Regulatory Affairs, Market Access and Marketing strategies

Chicago, IL

Senior Manager, Medical Affairs

Chicago, IL

Maggio-Bayer

Chicago, IL

Senior Manager, Medical Affairs

Develop and manage budgets for medical activities and provides input into the affiliate budgeting and planning process
Develop the talent within the country Medical team to ensure effective succession planning and career development to meet current and future demands
Develops/executes internal and external education/internal training programs with respect to medical/clinical issues within the product line/therapeutic area
Provide proactive input in the strategic medical and marketing management
Develop effective relationships with key influencers and external organizations
Possesses/maintains a current familiarity of the published medical literature relating to the product line/therapeutic area and serves as a resource regarding clinical trends and their potential impact
Work closely with Associate Director on all aspects of Medical and Commercial Review Committees, including the medical review of promotional and non-promotional materials

present

Dallas, TX

Senior Associate Manager, Medical Affairs

Dallas, TX

Morissette-Kuhn

present

Dallas, TX

Senior Associate Manager, Medical Affairs

present

Analyzing of Medical Affairs processes and design to implement improvements
Work collaboratively across functional areas to achieve common goals
Develop and maintain key relationships with relevant thought leaders
Manage departmental and project-related budgets and reconciliation
Budget creation, approval, and management
Management of multiple projects across different areas of the Business
Communicate clearly and work collaboratively with internal teams, such as; sales and marketing teams, R&D and clinical affairs

Education Education

Bachelor’s Degree in Scientific Discipline

Quinnipiac University

Bachelor’s Degree in Scientific Discipline

Skills Skills

Ability to work in group setting and independently; ability to adjust to changing priorities
Knowledge of Baxter product lines/therapeutic areas is helpful. Knowledge of infusion pumps and IV access products use, workflows is desired
2+ years experience in a pharmaceutical, medical device, or biotech company. -Supervisory or clinical experience is highly desirable, with familiarity with ICH guidelines/GCP
Ability to project and maintain a professional and positive attitude
Strong motivational skills and abilities – promoting a team based approach
Strong organizational skills and leadership skills
Strong interpersonal and communication skills, both verbal and written
Experience in
At least 3 years related experience
Post-full-registration experience in hospital practice

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Senior Associate Manager, Medical Affairs Resume Examples & Samples

Develop training and educational materials and programs including but not limited to; educational websites, live training programs and presentations and special projects as needed
Responsible for management of all educational content and materials related to the diagnostics product lines and associated disease states, as well as related industry trends and publications
Develop and maintain key relationships with relevant thought leaders
Provide support services for field and physician-facing databases and/ or systems
Liaison with marketing and sales to ensure compliance and consistency with regard to educational materials, training programs and clinician communications
Liaison with regulatory and legal to ensure compliance with state and federal regulations pertaining to physician payments and education of healthcare providers
Manage departmental and project-related budgets and reconciliation
Communicate clearly and work collaboratively with internal teams, such as; sales and marketing teams, R&D and clinical affairs
Serve as an acknowledged expert on company’s products and related competitive products in all areas relevant to internal and external customers: clinical, scientific, technical and health economics
Drive for outstanding results incorporating a sense of urgency when pursuing goals
Demonstrate ability to think strategically, set and manage priorities, manage multiple projects and allocate and reallocate resources as required
Work collaboratively across functional areas to achieve common goals
Proven strong interpersonal skills
Knowledge and understanding of medical and clinical terminology
Excellent oral and written communications skills as well as presentation skills and the ability to effectively educate on Hologic’s position to various stakeholders
Computer skills to include Power Point, Excel and Outlook
Attention to detail and ability to meet deadlines
Strong organizational skills with the ability to multi-task and adjust to changing priorities
Knowledge of healthcare compliance guidelines
3-5 years of experience in working with healthcare/medical professionals
2+ years of medical education experience in a medical device, diagnostics, or biotechnology environment
Experience developing and delivering educational programs preferred

Senior Associate Manager, Medical Affairs Resume Examples & Samples

Experienced project manager with proven track record of independently, passionately and effectively driving the delivery of new, high quality projects and initiatives
Act as an independent leader of Medical Affairs projects and other product-sustaining initiatives involving a cross-functional team
Establish project objectives and work plans including budgets and resource requirements. Delegate assignments to functional area team members and track key project activities to successful completion
Strong emphasis on exceeding customer expectations, while maximizing value to Hologic and maintaining compliance
Experienced leader well-versed in working within a matrixed organization
Specific responsibilities include
Database and vendor management
FDA-required reporting and data management
Project planning
Budget creation, approval, and management
Resource planning and allocation; and initiation and maintenance of project communications
Coordination and support of project team meetings, as needed
Gathering, organization, and management of project documentation, including: project statements, resource requirements, business requirements, business cases, performance metrics, and project plans
Analyzing of Medical Affairs processes and design to implement improvements
Support of project team meetings to gather and organize project business and technical requirements, establish budgets, timelines, issues, risks, dependencies, and constraints
Communication, presentation, and clarification of status to cross-functional project teams and Business leaders
Creation and maintenance of strong internal and external customer relationships
Management of multiple projects across different areas of the Business
Anticipation of potential issues and proactive troubleshooting, escalation, and problem solving, as needed
Knowledge and experience in Project Management
Experience with KOL/ Thought Leader Management
Experience in management of project risks
Strong communication and teamwork skills
Must possess excellent relationship building skills with team members, peers, and senior leaders accessing their needs and ask the right questions to surface essential requirements information
3 - 5 years of experience project or thought leader management
Experience with imaging and/or medical products or devices preferred

Manager, Medical Affairs Resume Examples & Samples

Support the medical Director by conducting operational office-based medical affairs business tasks includes e.g
Prior experience of commercially oriented positions
Prior experience of clinical trials management and understanding of GCP
Understanding of Health Economics
Technical knowledge in the Neurology disease/therapy area
Proven expertise in working with and within ABPI code of practice

Senior Manager, Medical Affairs Resume Examples & Samples

Provide medical expertise in support of company initiatives
Develop and manage scientific advisory panels and scientific relationships, and provide technical expertise to the company including Marketing, R&D, and bioMérieux Education
Assist in the training and operations
Help determine medical value of existing products and new product opportunities
Serve as scientific and medical consultant to program teams to enhance development of appropriate product requirements
Validate and/or expand product claims by interacting with Clinical Affairs and Marketing
Support RA/QA in risk assessment
Determine the impact of test results on clinical decision making and patient safety
Help define, in coordination with programs and marketing, the need for medical and economic outcome studies to demonstrate clinical and economic value in support claims
Assist in managing post-marketing research portfolio
Become a medical reference for the company
Attend congresses and other scientific meetings, sharing information with relevant stakeholders both internal and external to the company
Plan and participate in company-sponsored scientific symposium
Represent bioMérieux in local, regional, national and international scientific committees and medical societies
Medical Doctor or Clinical Pharmacist with at least 7 years relevant experience
Experience in Clinical Microbiology, Clinical Immunology, or Infectious Diseases is preferred
Strong interpersonal and diplomacy skills
Presentation and training skills
Ability to create, motivate and work in a team environment
Flexibility and adaptability
Practice experience preferred
Experience in Industry is highly preferred
Knowledge and experience of healthcare systems in North and/or South America is an asset

Senior Manager, Medical Affairs Resume Examples & Samples

Support the development of clinical data through Medical Affairs Sub-Team to include Gilead-sponsored, investigator-sponsored and collaborative studies
Assist with Gilead-sponsored Phase 4 studies
Prepare presentation materials and present scientific data at Internal and External Meetings involving Medical Affairs (e.g., including at Advisory Boards and Investigator Meetings)
Lead the medical affairs review of promotional material for HCV (Promotional Review Committee)
Lead the medical affairs review of drug safety materials for HCV
Develop effective working relationships with internal and external customers, including Clinical Research, Biometrics, Commercial and Marketing, Contracts/Finance, Virology, Pharmacology, Legal, Medical Scientists and other Gilead Medical Affairs colleagues, Medical Directors/Medical Managers in affiliate offices, investigators, research organizations
Experience in infectious diseases, virology or clinical virology is desirable
Experience in clinical patient care
Excellent organizational skills to support project planning across multiple activities, anticipate and prioritize workload
Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills
Excellent analytical skills, demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications
Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials

Group Manager, Medical Affairs Resume Examples & Samples

Support strategic planning and execution of projects to generate real world data in support of Vectra DA
Collaborate with internal stakeholders such as sales and marketing through activities such as document reviews, training and education
Collaborate with and support the managed care group through the generation, dissemination and presentation of data for payers
Manage relationships, contracts and projects and represent the scientific and medical team on collaborative projects with academic and/or pharma partners
Lead and conduct biomarker studies in rheumatology; identify and analyze relevant internal and external datasets; generate and interpret data; ensure timely exchange of biomarker and clinical data, statistical analyses, and study reports
Develop study plans in collaboration with internal and external stakeholders
Support statistical analysis plan developments and review their alignments with the study plan
Conduct due diligence work and evaluate the potential benefit of testing Vectra DA or other biomarker of interests in patients with rheumatoid arthritis treated with drug with novel mode-of-action
Contribute to the development and implementation of the publication strategy for Vectra DA
Write and work closely with the medical writer, publication manager, legal team and collaborators to ensure publication of study results in top ranking peer-reviewed journals
Drive timely generation of study reports and presentation of scientific and clinical findings internally and externally at international conferences
Prepare scientific material and summary of study findings to support new data roll-out and training of the sales team and others as necessary
Monitor scientific publications in rheumatology and attend scientific meetings
Contribute scientific and system biology expertise and to new product development
Support the commercial, marketing and business development activities
Willingness to travel (20-40%)
PharmD, MD, DO and/or PhD in biology, immunology or other related discipline with a minimum of 7 years of relevant work experience in pharmaceutical/biotechnology industry
Demonstrated study leadership and management skills; Experience managing projects and/or collaborations with academic and industrial partners
Ability to manage multiple projects and engage stakeholders in a dynamic environment with tight timelines
Ability to think quantitatively, interpret clinical trial data and interact with biostatisticians
Superior communication skills, both oral and written; able to prepare PowerPoint presentations (informal and formal) and present data to specialized audiences
Biomedical writing experience with history of peer reviewed publications
Dynamic, self-starter, adaptable and flexible to a growing company, comfortable handling uncertainty
Strong work ethic with expectation of excellence from self and others
Willingness to travel (no more than 25%)

Manager, Medical Affairs Resume Examples & Samples

Strong motivational skills and abilities – promoting a team based approach
Strong organizational skills and leadership skills
5 + years’ experience working with clinical trials and/or within pharmaceutical environment required
Experience with multi-modality imaging projects required
Experience with medical imaging software a plus
Experience working with computer software including Word, Excel, Access and Project preferred

Senior Manager, Medical Affairs Operations Resume Examples & Samples

3-5 years of professional experience, preferably in the biotechnology / life sciences industry; strong project and process management experience with a focus on continuous process improvement
Able to establish priorities among competing projects and able to juggle shifting priorities with ease
Applies problem solving skills to move projects forward and identify key project issues; resourceful and quick to learn
Superior organization skills with acute attention to detail
Excellent professional oral and written communication skills in order to establish working relationships with internal customers
Demonstrated persistent follow through, results- and solution-oriented
Exercises professional judgment on engagements by providing proactive solutions and recommendations
Comfortable in a dynamic working environment, at times ambiguous
Operates effectively in a fast-paced, deadline-driven environment

Trial Manager Medical Affairs Operations Resume Examples & Samples

Leads the SMT as the single point of accountability for end-to-end project management of local company data generation activities in one or more countries
Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 5 years of clinical trial experience in the pharmaceutical industry or CRO
Excellent project management skills combined with proficient communication skills are required. Flexibility and ability to manage study teams in a virtual environment are needed
Knowledge of Computer literacy is necessary
Excellent decision-making and strong financial management skills are essential
Ability to work on multiple projects in parallel in different therapeutic areas is required
Experience in managing all study types (interventional, non-interventional, registries) is preferred
Fluent German and English Skills (both verbal and written) are necessary

Scientific Manager Medical Affairs Resume Examples & Samples

Develops and leads biomarker and CDx strategy in medical affairs programs
Ensures implementation and execution of BM strategies in global medical affairs studies and projects (including input and authorship for study protocols)
Leads and drives biomarker data analyses and interpretation of medical affairs projects and studies and publishes data at conferences and peer reviewed, high quality scientific journals
Serves as the single point of contact for affiliates for questions on translational research/CDx development and provide strategic guidance and technical expertise to respective teams around the world
Develops study proposals in collaboration with TAEs to address data gaps and strategies in context of companion diagnostic test development and implementation
Provides expert scientific advice to commercial teams in connection with the launch and commercialization of pharmaceuticals with a Companion Diagnostic
Leads the development of biomarker-related educational and promotional materials and training programs (e.g. for physicians, pathologists)
Provides input into Publication Planning for translational research

Manager, Medical Affairs Operations Resume Examples & Samples

IT Liaison
Minimum 4 years of related experience in the biotech/pharmaceutical industry, including experience working with business solutions implementation and process documents
Experience in the pharmaceutical industry with business solutions support, technology support and/or process improvement or quality background strongly preferred
Problem solving skills and results orientation
Ability to work in a global team environment and work effectively with remote colleagues
Ability to multi-task and work in a high volume environment

Senior Manager, Medical Affairs Resume Examples & Samples

Support the development of medical education materials, ensuring that the content is medically accurate and appropriate
Work closely with Associate Director on all aspects of Medical and Commercial Review Committees, including the medical review of promotional and non-promotional materials
Perform medical fact checking of promotional and non-promotional materials such as slides, brochures and other documents as needed
Work with the Associate Director in the support of US phase IV research efforts, as needed
Able to review and interpret patient data derived from clinical trials, registries, published literature, etc. and translate the information to audiences with diverse backgrounds
Stay abreast of current scientific and medical trends in CF disease and drug development and awareness across the organization of key published data in clinical trials, publications and conferences
Understanding of government and industry guidelines, regulations, laws, etc. for promotional and non promotional materials
Advanced degree (MD, PhD, PharmD, ex-US medical degree)
2+ years pharmaceutical industry experience; Medical Affairs experience preferred
Excellent interpersonal skills with demonstrated ability to work collaboratively in a team-based matrix management environment
Must be detail-oriented, have excellent planning, time management and organizational skills, and the ability to work independently while organizing multiple tasks and meeting aggressive deadlines
Flexible and able to keep up in a fast-paced environment
Strong communication and judgment skills with a proactive attitude to assist and anticipate the needs of the department
Familiarity with pulmonary disease or Cystic Fibrosis in particular is considered a plus
Strong literature search and evaluation skills

Program Manager, Medical Affairs Resume Examples & Samples

BS/BA in science or engineering/MBA or MS in engineering preferred
Minimum 5 years relevant experience in business operations and project management
Certification as a Lean Six Sigma Black Belt from a recognized authority preferred
PMP and/or RMP certification preferred
Understanding of process leverage, end to end enterprise oversight experience desired
Comprehension and understanding of Clinical Affairs/Medical Affairs affairs functional systems and processes will be desired
Excellent training and communication skills
Proven ability to directly lead and/or co-lead multiple high-impact process improvement projects
Excellent change management skills
Strong project management, planning and organizational abilities
Computer proficiency with Excel, Word, Power Point
Well versed in analytical tools and dashboard generation

Senior Business Manager, Medical Affairs Resume Examples & Samples

Business Manager to the MLT, USMA Forum, NA Regional Leadership, and other collaboration forums/initiatives
Facilitate smart goal setting, and operational approach to achieve near-term and long term objectives
Design, prepare for and effectively facilitate the meetings and forum/committee interactions (agenda setting, minutes, and outcomes and action item management)
Build and maintain positive working relationships with customers and key stakeholders, leveraging interpersonal and influence skills
Effectively communicate to all levels in the organization – individual contributors, management/sponsors and external stakeholders
Partner with MBO colleagues to generate content for key communication channels and deliverables
Facilitate quarterly MLT off-sites with planned agenda aligned with team development plan
Facilitate quarterly North American LT joint meetings in collaboration with Canadian Med Affairs business manager
Facilitate annual PDMA/USMA joint LT meetings in collaboration with Global Med Affairs business manager
Develop content for monthly MLT communication
As a member of the Medical Business Operations (MBO) Leadership Team, contribute to the development and delivery of departmental goals
Business excellence: Good at developing the processes necessary to get things done, knows how to organize people and activities, and knows how to apply design thinking and problem analysis frameworks. Demonstrates an ability to work in unstructured and ambiguous environments
Collaboration: Applies curiosity and continuous learning to effectively collaborate in and across multiple organizations, and with stakeholders of various background and skill set. Skilled in establishing and facilitating a collaborative and respectful team/group environment
Communication:Able to simplify a complex set of components into a simple, effective message or communication plan. Strong executive presentation skills and writing skills. Initiative: Able to define priorities and focus on areas that add value. Self-motivated and disciplined to deliver results
Influencing: Demonstrated skills in persuading senior leadership on strategy, initiatives implementation and decision-making. Possesses a strong self-awareness to apply appropriate influence skills in varied situations and with various levels in the organization to achieve business objectives
Problem solver: Demonstrate ability to develop and present sound proposals and recommendations. Brings experience in implementing and embedding solutions, not just information-gathering to management
Leadership: Understands the impact of own actions and programs across the business. Able to make decisions taking multiple perspectives into account

Manager, Medical Affairs Portfolio Resume Examples & Samples

BS Degree
Finance and controlling experience
Ability to make decision and work independently in an international and non-financial environment
Excellent analytical and organizational skills, highly accurate
Strong Negotiation and persuasion skills, self-motivated
Team player, keen on receiving or sharing expertise and best practices
Ability to present and to train non-financial collaborators
MBA
Knowledge in international clinical study conduct
Biology skills or engineering school with cost center skills

Associate Manager, Medical Affairs Resume Examples & Samples

The Associate MAF Manager’s mission is to support the quality use of our medicines through clinically relevant and scientifically robust interactions with leading specialists as a trusted scientific counterpart
Associate MAF Manager is jointly responsible to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and company goals
Associate MAF Manager is expected to be a therapeutic area scientific expert, responsible for discussing the Company products, patients’ treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart
Associate MAF Manager is required to develop and implement strategies related to market access, government affairs and public health initiatives
Develops an annual plan and calendar of activities in support of the marketing plan that would provide ample product exposure to the targeted doctors, treatment centers and medical societies
Prepares medical education budget in relation to Society Convention and Johnson & Johnson initiated Symposiums
Assumes the role of project manager for all Symposiums (Lunch Symposiums, Post Graduate Lectures, Johnson & Johnson initiated activities) or all activities which will involve the transfer of scientific knowledge by way of a lecture. This will include arrangement of the venue and program preparation
Achieves a desired participation as planned in activities of target medical societies or organizations
Conducts medical education activities and programs efficiently and effectively in accordance with HCC as approved in the annual plan and /calendar of activities
Develops Key Opinion Leaders (KOLs) and company pool of speakers
Coordinates with Marketing on the creation of Marketing Advisory Boards/Councils
Conducts training for employees regarding the disease area handled
Assists/provides inputs to product manager for training of sales force
Provide inputs to medical science liaison for queries/requests for medical information, as appropriate
Coordinates with the Marketing and the sales force in organizing the CME activities from planning to implementation and assist in the follow-up plan. Focusing on Medical Education Key Messages that will be included in the modules
Participates in planning of marketing activities/strategies
Provides key support for relevant audits/inspections
Conducts or implements clinical study within the assigned Therapeutic Area
Works with different government and non-government institutions to help improve access to medicines and healthcare landscape of the country, especially on the therapeutic areas where the company is specializing on
Degree in any medical-related or scientific-inclined courses such as pharmacy, nursing, medical technology and others. Masters/medical/doctoral degrees are of advantage
Must possess leadership and organization skills including the ability to communicate motivate, train people, manage resources and make decisions as well as organizational skills and self-confidence
Must exhibit an understanding and consequent application of product management concepts, as applied in the field
Must have strong knowledge experience in the area of public health/government affairs/market accessMedical Science Liaison

Program Manager Medical Affairs & Biometrics Resume Examples & Samples

In collaboration with sponsors, solution owners and other stakeholders, identify and secure team members to support the project delivery and ensure clear roles and responsibilities
Manage the triple constraints (Cost, Schedule, Scope/Quality) of the project delivery
Provide accurate, timely and fit-for-purpose project status reports and financial forecasts, using established norms and reporting tools and escalate to senior stakeholders as needed
Identify, analyze and communicate holistically impact of scope changes throughout the project lifecycle
Ensure effective internal (within project team) and external (other teams, related-systems, end user communities) communication for the projects you are in charge of

Project Execution Manager, Medical Affairs Resume Examples & Samples

In this position, you will be primarily accountable for consistently, effectively: Where applicable, developing and maintaining an in-depth understanding of the therapeutic area strategy, disease areas, and relevant clinical, patient, payer and market landscapes
Playing a role in the development of 3-year and 1-year medical strategies, plans and tactics, including budget and resource plans
Help teams execute functional or medical plans; guiding cross-functional partners and stakeholders to high quality, timely and within budget results, including proactive risk management and mitigation
Develops and cultivates important relationships with internal and external partners and stakeholders
Contributes to the ongoing development of Genentech’s Project Team System; including sharing best practices, lessons learned, identifying cross-project opportunities, dependencies and efficiencies
When assigned, identifying and completing special projects
Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget
Ensure coordination and alignment between Field Medical Team and Spectrum Operations team
Build and grow brand awareness for Spectrum FMT to targeted internal stakeholders
Build and strengthen Spectrum FMT communities through social media or virtual platforms with the implementation, documentation and storage of MSL training plans
Build and maintain team repositories (e.g. gSite, Touchpoint, Quosa, eMAP/IShare) in accordance with GNE record retention and compliance rules Maintain document control, database management, track project activities and team communication
Assists MSL leadership team in strategic meetings. Prepare meeting agenda, minutes, and team reports for the Spectrum MSL team
Work with MSL leadership team to coordinate and conduct meetings- keep stakeholders on time, meetings on budget and develop and analyze post-meeting surveys
Work with Finance, Legal and other partners to evaluate plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects
Works within and across USMA and relevant departments and cross functional teams to ensure alignment and synergies of strategies, plans, objectives and tactics
Inform and align MSL and Spectrum Leadership Team and Medical Teams goals and objectives
In collaboration with the MSL Leadership team, prepares, analyzes and communicates qualitative and quantitative information for executive level audiences
Works closely with the MSL Leadership Team and other cross functional partners to develop short and long-term strategies, plans, tactics, budgets and other resource plans
Proven track record of meeting or exceeding objectives and goals
Outstanding attention-to-detail
Ability to prioritize workload and maintain flexibility as things change
Proven project and process management skills and understanding of best-practice project management methodologies, techniques and tools
Strong financial acumen: capable of effective planning and oversight for large-scale project budgets
Good interpersonal and influencing skills: can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority
Business travel, by air or car may be required

Manager, Medical Affairs SMA Resume Examples & Samples

Supporting and coordinating execution of the Nusinersen EAP in the region
Developing concept and facilitating harmonization/improvement of the current national SMA disease registries in the Region together with SMA Scientific community
Providing medical training, medical scientific advise , medical project support primarily to MSLs and other regional functions like Market Access, PAG management, Marketing, Business Ops
Be an active member of the regional SMA Medical team and partner in cross functional eLOT team
Independent team worker
An insight and/or interest in Neuromuscular Disease and Pediatric neurology is essential

Senior Manager Medical Affairs Resume Examples & Samples

Provide medical guidance and category knowledge to support existing products promotional activities and participate at local review/approval process
Lead the planning and implementation of medical/clinical programs in support of assigned brands
Maintain responsibility for point of view development, publication monitoring and claim support
Interpret clinical study data and medical literature search material relevant to categories
Build relationships with key opinion leaders, societies and institutions while working with emerging scientific discovery to keep the competitive edge of the assigned product brands
A Healthcare Professional (PharmD, PhD or MD) with 2 years of postgraduate training or equivalent experience within the pharmaceutical industry
Experience in medical affairs, and/or clinical research and development is required
Experience working with the brand team and other cross functional business partners is required
Strong communications skills, both oral and written
Ability to interact collaboratively and influence colleagues at all levels within Bayer
Knowledge of scientific information searches
Key opinion leader development and clinical knowledge
Excellent interpersonal communication and presentation skills, including ability to network and present critical medical and scientific information to internal departments
Ability to interact with external customers, medical thought leaders, and academic communities
Experience working within the allergy/respiratory category is preferred

Manager, Medical Affairs & Credentialing Resume Examples & Samples

Conducts, Participates In, Maintains and Manages the Credentialing and/or Privileging Process ensuring they are conducted in an accurate and timely manner
Conducts, Participates In, and Maintains Primary Source Verification
Conducts, Participates In, and Maintains Current Clinical Competency Evaluations and Peer Review
Manages Compliance with Accreditation Standards and Regulatory Requirements, Policies and Procedures
Assists in development, coordination and integration of quality metrics into the ongoing and focused evaluation of physician and advanced practice professionals professional performance
Participates on various Henry Ford Allegiance Health and Henry Ford Health System committees
Manages Departmental Operations (Personnel, Budget, etc.), sets short and long-term departmental goals and objectives that align with Henry Ford Allegiance Health and Henry Ford Health System strategic objectives, and directs, develops, implements and evaluates departmental quality assurance programs
Manages Medical Staff Functions (assists with orientation of new medical staff, prepares reports for medical staff, executive and governance committees, plans and implements schedule for medical staff meetings; including continuity of topics, materials, notices, documentation and follow-up)
Three (3) years of experience in Medical Staff services
Previous healthcare experience with demonstrated knowledge of Medical Staff Policies and Procedures and medical terminology is required
Demonstrated leadership ability, communications, and interpersonal skills necessary to interact effectively with physicians, management, administration, and staff is required
Excellent interpersonal, written, and oral communication skills are required
Proficiency with personal computers and related software is required
Demonstrated ability to maintain confidentiality is required
Demonstrated skills to work with deadlines, manage multiple priorities and multiple stakeholders and function independently is required
Ability to work flexible schedule in order to provide coverage for meetings is required

Senior Manager, Medical Affairs SMA Resume Examples & Samples

Supporting and coordinating execution of the Nusinersen EAP in country/Cluster
Developing the medical scientific presentation, and communication content
Supporting local affiliate approval process of all materials and documents
Supporting the planning preparation and execution of national SMA Advisory Boards
Devloping of the country specific medical tactical plan, including implementation of regional projects
Providing medical training for local affiliate and medical project support primarily to MSLs and other local affiliate functions like Market Access, PAG management, Marketing
Be an active member of the regional SMA Medical team and partner in affiliate cross functional team
5+ years of relevant work experience, ideally in rare disease area
Independent team worker, pro-active and self-starter
Excellent Communication, interpersonal skills and organizational skills
Flexible mind-set, ability to navigate in ambiguous environment
Fluent in French, Flemish, and English
Preferably a Medical Physician. Pharmaceutical/ life sciences background

Senior Manager, Medical Affairs, Immuno Resume Examples & Samples

When necessary represent Medical Affairs in cross functional teams/meetings, eg Project Teams, Clinical Sub-teams and Medical sub teams
Work with Disease leads to collaborate with all disease representatives and functional teams in Medical Affairs on Disease strategy and tactics
Support and may lead Medical affairs cross-functional sub team meetings
Write, develop, and amend post-marketing, non-registration clinical study protocols, consent forms, and case report forms in collaboration with study teams
Independently lead the execution of one or more trials or disease registry
Review of ongoing clinical data, tables, figures and listings along with patient profiles to determine safety and efficacy endpoints for company sponsored and/or registry studies
Support/lead in the execution of national/community advisory boards and steering committee meetings
Represent company at professional meetings, congresses, and local symposia
Assist with and I-O Disease Strategy and Plans
Track priority Medical Affairs tactics in Disease Plans
Partner with Sci Comm on developing disease publication strategy, gap analysis, key messages
High quality scientific/clinical input and review of (as needed)
Minimum 2+ years pharmaceutical/biotech industry or related experience is required
Previous experience with clinical/medical trials is required; previous experience in Medical affairs preferred
Proficient in critical data review, data cleaning and interpretation
Strong Leadership skills
Able to lead & work in matrix organization
Travel required (approx. 10 - 15% monthly)

Senior Manager, Medical Affairs, Trauma & CMF Resume Examples & Samples

A minimum of a Bachelor’s Degree (or equivalent university degree) in a scientific discipline is required
Professional nursing licensure (e.g. RN, BSN, NP, PA, or equivalent) is required
A minimum of 10 years of clinical practice in an acute care surgical setting is required
A minimum of 8 years of orthopedic medical device industry experience is required
Experience interpreting and working within US and OUS health authority regulations is required
Global regulatory work experience is required
Knowledge of and hands on experience with 21 CFR 820.30, 21 CFR 803 and 21 CFR 806 is preferred
Strong leadership and collaborative skills and a demonstrated ability to build successful relationships with cross functional stakeholders is required
The demonstrated ability to lead teams is required
Advanced proficiency in Microsoft Office (Word, Excel, and PowerPoint) is required
This position will be located in West Chester, PA and will require up to 20% domestic and international travel6993170405

Manager, Medical Affairs Resume Examples & Samples

Works cross-functionally with local brand team members (marketing, market access, public affairs etc.) to develop and maintain sustainable value propositions for the MS assets, with patients at the center
Conceptualizes relevant data generation projects/studies
Lead IIT alignment and preparation for internal review
Develops and maintains a network of external experts (KOLs) and corresponding engagement plans (at local level)
Chairs local advisory board meetings
Develops a proactive approach to gathering TA scientific and market insights allowing anticipation of issues and opportunities
M.D., D.O., or equivalent degree with work experience in the area of Multiple Sclerosis
Minimum 5 years of progressive experience in the therapeutic area, preferably in the biotech or pharmaceutical industry or similar academic institution
Effective communication at all times. Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
Ability to effectively interact with teams of peers and to work closely with both external physicians/scientists and numerous in-house support groups
Must be able to conceptualize and articulate a vision for self and the franchise that energizes all functional areas and stakeholders
Knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies
Fluent in English/German - French language skills preferred

Senior Manager, Medical Affairs Resume Examples & Samples

Provide proactive input in the strategic medical and marketing management
Share knowledge and technical expertise with other team members
Develop and implement strategic direction within key therapeutic areas
Develop effective relationships with key influencers and external organizations
Collaboration in cross-functional teams and in formulating and implementing medical strategy
Develop and design of external scientific deliverables
Answer medical questions on products
Provide training to field representatives and other internal staff
Initiate and facilitate clinical trials – Celgene sponsored and investigator initiated
Lead/Supervise/Coach planning, execution and reporting of key projects (e.g, Advisory Boards, communication events, Satellite Symposia, etc)
Provide medical input for regulatory submissions and reimbursement dossiers (Swissmedic, BAG)
Scientific support of physicians wanting to treat patients with Celgene products at any registration stage and indication
Identify, leads and/or fosters overarching projects within the local medical affairs hematology & oncology team such as training needs
Acts as the deputy of the Medical Director
Lead medical affairs hematology & oncology team
Preferable Medical Degree or Masters Degree in Pharmacy, Chemistry, Biology or in other relevant medical scientific fields
Minimum 8 years business experience required in the biotech- and/or pharmaceutical industry, in the Swiss market, preferable in the hematology/oncology field
Strong Leadership skills, previous line management required
Excellent understanding of commercialization process and clinical development. Knowledge of molecular biology and pharmacology
Excellent communication and project management skills
Excellent skills in interacting with internal and external stakeholders
Strong computer skills required, specifically Windows software, including Word, Excel and PowerPoint and Outlook
Fluent written and spoken German, English, French desired

Program Manager, Medical Affairs Resume Examples & Samples

Facilitate weekly strategy meetings for assigned products, including drafting agenda as well as compiling and distributing meeting minutes
Work with Medical Directors to ensure timelines, deliverables and goals are being achieved for assigned product strategy teams
Work cross-functionally with Product Program Managers and Product Leads to ensure transparent communication of Medical Affairs strategy is being flowing bi-directional
Develop, track, and report project activities, to include timelines and budgets
Manage the oversight of the development and implementation of multiple product-specific scientific platforms
Manage external vendors responsible for the Scientific Platforms
Communicate to key internal stakeholders the status of project activities
Collaborate with leaders from multiple departments with regards to content and design of each scientific platform
Minimum 2 years of experience in project management related activities
Medical Affairs or related field in the industry, preferred
Ability to lead initiatives within Medical Affairs and cross functionally
Knowledge of pharmaceutical industry regulations, guidelines, standards and practices preferred
Demonstrated problem solving skills in a complex and matrixed environment and in complex situations

Senior Manager, Medical Affairs Resume Examples & Samples

Establishes the scientific reputation of local BIIB affiliate; develops strong peer-to-peer scientific partnerships with thought leaders in alignment with overall BIIB strategy
Lead development of the affiliate medical plan aligned with regional and global plans, partnering with the affiliate management team, including Market Access, Marketing and Sales and other functions to define, establish and execute a coherent local business plan that addresses patient needs; identifies measurable goals to insure execution of local medical affairs plan
Partner and collaborate with commercial and market access to demonstrate medical value of Biogen products relevant to local external stakeholders (payers, HCPs, agencies); may include providing input to all clinical trials (pre and post-marketing),developing and executing phase IVs, registries, etc.(master real-life medicine)
Acts as a local partner for R&D for pipeline and new products
Develop and manage budgets for medical activities and provides input into the affiliate budgeting and planning process
Building a high performing organization
Lead the local Medical team providing strategic direction to maximize business return
Develop the talent within the country Medical team to ensure effective succession planning and career development to meet current and future demands
Drive organizational development and changes and structure in line with business growth
Lead and motivate the medical organization to have the professional approach on top
Assigns work effectively, with appropriate dialogue re context, specific accountabilities and goals, milestones, resources
Influence and inspire teams to perform at their best
Develops and nurtures a team oriented culture
Provide coaching feedback and advice that is separate from tactical support
Prepares and presents effective performance reviews including goal setting, mid-year review and year-end appraisal
Ensure all team members are fully aligned and comply with Biogen regulations and local laws
Ensure compliance within the team with Biogen code of business conduct
Pharmacovigilance
Ensures and oversees the operational functioning and compliance with all applicable external and internal regulations In pharmacovigilance (adverse events reporting), regulatory and review of promotional materials. Evaluates and implements the outsourcing tasks in these areas in an effective and efficient way to free up internal resources for other medical activities/projects
Contact person for official departments for all medical relevant Information
Vendor oversight
Clinical Studies
Develops, approves and implements clinical studies at local level and gives support for international clinical operations projects
Ensures close co-operation/alignment with marketing/sales/Market Access in all support activities
Delivers medicaI information to external customers/physicians on time
Presents medical information and results to external customers/physicians including at Advisory Board Meetings
Provides scientific briefing to the customers for scientific presentations and lectures
Delivers the product and other medically related training and information to internal/external customers proactively, timely, effectively and according to the SOPs
CRO oversight
Job holder must respect internal rules and all rules based on the respective legal and ethical (AIFP codex) standards. Any safety related information concerning Biogen products (adverse event I suspicion on adverse event etc.) must report to the Affiliate Safety Designated Staff in accordance with current internal company rules. Any quality related information concerning Biogen products (product complaints I product defects I suspicion on product defects I falsified medicinal products etc.) must reports directly to the Manager, Quality & Governance in accordance with current internal company rules
8+ years of relevant work experience, in pharmaceutical or biotechnology industry
Experience in publication planning and implementation, planning and executing CME programs and symposia, and developing medical education materials
Ability to interpret and organize highly complex scientific data
Experience in working closely with scientific/medical experts and authors, KOLs and HCPs
Strong oral and written communication skills and collaborative interpersonal skills
Must have strong project management skills and ability to successfully manage assignments on time with high quality
Strong presentation skills. Precise and accurate working style
High sense of responsibility
Fluency in Polish and English

Senior Manager Medical Affairs Resume Examples & Samples

Acts as Medical Publication Lead and drives the medical publication strategy. The Medical Publication Lead is accountable for the delivery of the publication items and leads vendors in operationalizing the strategic publication plan, through building and leading a high-performing team. Communicates strategic and complex concepts in a simple manner to multidisciplinary teams. Ensures medical publications are delivered according to publication plan and predefined quality criteria. Plan and coordinate abstract submissions for major congresses. Identify new publication opportunities and collaborate with R&D functions to explore new content for publications
Function as central medical expert for activities related to assigned product area for internal stakeholders (regulatory affairs, drug safety, clinical R&D and global health economics) as well key customers of the medical community. Recruit and integrate external knowledge into internal developments and marketing initiatives in collaboration with regions
Identify and evaluate new opportunities of KOL interaction of assigned product area. Monitor scientific progress and competitive activity in the assigned product area. Devise and implement global KOL strategy and develop, maintain contacts to KOLs
Propose and encourage relevant global investigator initiated research projects with key experts of the assigned therapy area in cooperation with therapy area head as well as other team members. Responsible for evaluation of requests for investigator led studies and research collaborations
Identify, develop and implement medical marketing initiatives (i.e. congress symposia, advisory boards, medical education/grant program). Contribute to development of medical and educational core promotional material and publications. Provide input into product development plans, in particular the clinical research program and design of clinical development plan (in collaboration with R&D)
Manage medical budget
Competencies

Associate Manager, Medical Affairs Resume Examples & Samples

Evaluate and translate complex scientific/clinical data
Provide medical review of promotional materials in conjunction with the Promotional Review Committee to ensure scientific accuracy, clinical relevance, and compliance with Regulatory guidelines
Write abstracts, manuscripts, and advisory program executive summaries; create presentation slides for medical conference, advisory programs, and personnel trainings as delegated by the Director
Provide training on PrEP and HIV Prevention for Medical Affairs and Commercial personnel
Create new hire training materials in conjunction with Commercial Learning and Development
Support activities related to medical conferences including review of relevant scientific information to create/update Topical Slide Decks, SRDs, and AKQs
Work collaboratively with personnel across multiple functional areas, including Medical Science, Medical Information, Commercial, Marketing, Clinical Research, Drug Safety, Regulatory, Public Affairs, Government Affairs and Legal
Knowledge and appreciation of all applicable regulatory and legal requirements for Medical Affairs activities is essential, as is accountability for serving as a role model for others in line with Core Values
Advanced degree (i.e. MD, DO, PharmD, PhD, NP/PA) required with ≥2 years of relevant clinical practice experience in PrEP and/or HIV. Experience in pharmaceutical industry is preferred but not required
Expertise in PowerPoint, Excel and Word
Ability to effectively prioritize and work on multiple projects simultaneously

Associate Manager, Medical Affairs Resume Examples & Samples

Draft, negotiate, and execute the full clinical contract lifecycle for a variety of progressively complex contract types (e.g., educational grant agreements, investigator initiated study (IIS) agreements including budgets, vendor contracts including RFP process), utilizing appropriate Edwards systems (e.g. Electronic Contracts Lifecycle Management System), and managing associated processes and web portals
Assess needs for contract and budget amendments and provide guidance to stakeholders, make recommendations, and/or negotiate changes, to terms and conditions while mitigating risks to the company. Identify and mitigate risks with low to moderate exposure to the company and create corrective action plans to prevent repeat of risks
Develop budgets (e.g. study and/or vendor) of minimal complexity based upon fair market value assessments with in-depth understanding of project scope in collaboration with investigator teams
Create basic contract amendment or termination letter templates. Provide input on basic legal owned contract templates
Bachelor's degree in related field with 8 years OR Master's or JD degree with 6 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes required
Contract or paralegal certification preferred
Experience in healthcare related contracts preferred
Proven expertise in Microsoft Office Suite and related contract systems
Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives

Manager, Medical Affairs Resume Examples & Samples

Be the scientific and medical expert about the disease and the product, including franchise strategies and tactics
Initiate and monitor medical projects, including supporting national clinical trials, protocol writing, publication, phase IV studies, IITs/SRA
Organize and conduct medical education events for different stakeholders including nurses
Develop and maintain scientific relationships with Key Opinion Leaders demonstrating detailed understanding of the therapeutic area and Biogen products, facilitating scientific exchange with Key Opinion Leaders
Min 2+ years of relevant work experience in the pharmaceutical industry (e.g. Medical Affairs, Clinical Research)

Senior Manager, Medical Affairs Resume Examples & Samples

Possesses an advanced understanding and maintains current knowledge of regulatory and quality requirements
Develops strategies and initiatives that improve and streamline current processes within GCMA to improve scientific data and communications services to internal and external customers
Oversees product development including clinical appropriateness reviews, design input and contribute to risk management activities
Must possess interpersonal skills and a demonstrated ability to manage conflict situations as well as a demonstrated record of responsible actions
Must also have excellent verbal/written communication skills, excellent presentation and teaching skills, be computer literate, and able to participate in a cross-functional team approach
Ability to influence, initiate, and accept change, and address complex, multi-faceted questions and issues
Demonstrates exceptional follow-through with respect to tasks and projects
At least 5 years related experience
Supervisory or clinical experience is highly desirable
Knowledge of Baxter product lines/therapeutic areas is helpful. Knowledge of infusion pumps, IV access and solutions, drug delivery devices, etc is highly desirable

Manager, Medical Affairs Resume Examples & Samples

Conducts strategic assessment (gap analysis) of information needs within the therapeutic area and develops fulfillment strategies (e.g., publication/research planning, educational activities, attendance at key medical meetings and advisory boards, etc.)
Provides expert clinical and technical product knowledge in response to clinical/medical inquiries from external and internal customers
Serves as a member of the advertising/promotional review committee representing Global Medical Affairs (GMA), and provides editorial input related to product line/therapeutic area
Develops/executes internal and external education/internal training programs with respect to medical/clinical issues within the product line/therapeutic area
Possesses/maintains a current familiarity of the published medical literature relating to the product line/therapeutic area and serves as a resource regarding clinical trends and their potential impact
Leads planning, development, and execution of product launches. Activities may include writing/amending package inserts, licensing submissions, and development of training materials
Participate in post-market research initiatives including development of safety surveillance registry protocols, study database analyses, and reporting
Develops strategies and initiatives that improve and streamline current processes within GMA to improve scientific data and communications services to internal and external customers. ? Oversees product development including clinical appropriateness reviews, design input and risk management related activities
Advanced degree in scientific discipline or equivalent
At least 3 years related experience
Nurse (BSN, RN) preferred
2+ years experience in a pharmaceutical, medical device, or biotech company. -Supervisory or clinical experience is highly desirable, with familiarity with ICH guidelines/GCP
Knowledge of Baxter product lines/therapeutic areas is helpful. Knowledge of infusion pumps and IV access products use, workflows is desired