Medical Affairs Director Resume Samples

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D Botsford

Derrick

Botsford

4264 Joy Inlet

San Francisco

+1 (555) 543 5941

4264 Joy Inlet

San Francisco

Phone

p +1 (555) 543 5941

Experience Experience

Boston, MA

Medical Affairs Director

Boston, MA

Robel, Romaguera and Borer

Boston, MA

Medical Affairs Director

Provide therapeutic knowledge or expertise on business development projects and manage Medical Affairs transition process after deals completed
Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
Provide areas of interest and general information regarding the Merck Investigator Study Program process
Providing physician leadership for scientific communications, including standard responses and publications
Oversee the development and presentation of scientific data to internal and external audiences
Work with the Global Medical Team leader and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
Support development of the in-year medical tactical plan and budget for the global initiatives and the United States

New York, NY

Medical Affairs Director NAF

New York, NY

Hammes, Witting and Swaniawski

New York, NY

Medical Affairs Director NAF

Member of the NAF Management team
Budget management
Develops together with team
Monitors actively MAF performance
Manages MAF budget
KOL Developments Plans
Quality of Medical Education events based on clear KPIs (NPS, Scientific evaluation)

present

Houston, TX

Medical Affairs Director Immunology IBD

Houston, TX

Hills Group

present

Houston, TX

Medical Affairs Director Immunology IBD

present

Networking and Collaborating
Quality Management
Project Management
Medical Strategy Development
In-depth knowledge with at least one product within TA including main competitors
Awareness of, and adherence to, Johnson & Johnson Credo values
Medical WritingMedical Affairs

Education Education

Bachelor’s Degree in Biomedical Sciences

The University of Texas at Austin

Bachelor’s Degree in Biomedical Sciences

Skills Skills

Excellent knowledge of the TA in general with a good knowledge of all products within TA
Possesses strong listening skills; ability to create win/win solutions; good sense of humor; viewed by subordinates as tough but fair
Ability to adapt easily to changing work environment; comfortable with ambiguity
Good knowledge of study execution, Global Medical Safety and regulatory affairs
Personable, likeable, engaging style that encourages a high morale and teamwork
Ability to convey, on a peer to peer basis, a therapeutic option in a fair, balanced and highly credible manner
Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
Strong leadership skills, capable of driving a multi-cultural, virtual team
Exhibits integrity, honesty and a sense of personal accountability
Innovative with the ability to coordinate and drive a complex and changing environment

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15 Medical Affairs Director resume templates

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Medical Affairs Director Resume Examples & Samples

20% - Support definition of global medical strategy and plans
Work with the Global Medical Team leader and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
As delegated by the Global Medical Team leader, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team
40% - Work with Global Medical Team leader on in-year implementation of global medical strategy
A medical degree is preferred, PhD or PharmD + >10 year experience required

Medical Affairs Director Resume Examples & Samples

Work with the EMAP Team to gather input for the EMEA Medical Affairs Product Plan(s) for designated product(s) according to the EMAP Team charter
Draft the EMEA Medical Affairs Product Plan for allocated product(s) and drive the review and approval process with the EMAP team, EMEA Therapeutic Area Team (ETAT), the EMEA Medical Affairs Leadership Team (EMALT) and IBVT
Work with the EMAP Team to proactively identify and provide medical input into opportunities for new indications or lifecycle extensions for allocated product(s)
Work with the EMAP Team to develop approaches to support successful market access for allocated product(s) in partnership with HEMAR, the CDT (Compound Development Team) and lifecycle management teams
Leverage product(s) expertise, medical and market insight to shape and direct implementation of product(s) strategies and plans
Work with the EMAP Team and Medical Affairs functional network to drive the implementation of the Strategy and Plan
Ensure effective and regular communications between Global, Regional and local MA teams, including regular communications to help minimise duplication of clinical, advocacy and access programs across countries, and facilitate co-ordination between EMEA Medical Affairs, CDT, Strategic Marketing, HEMAR and individual countries
Work with designated EMEA SKM Product Specialist(s) to integrate and align Medical Information requirements with the EMEA MA Strategy and Plan
In-depth knowledge with at least one product within TA including main competitors
In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis)
Strong leadership skills, capable of driving a multi-cultural, virtual team
Awareness of, and adherence to, Johnson & Johnson Credo values
5 + year industry / business experience with a minimum of 2 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
1 – 3 year project management, team leader or functional line management experience

Medical Affairs Director Resume Examples & Samples

Develop professional relationships and communicate with national and regional thought leaders to ensure access to medical and scientific information on Merck products and areas of therapeutic interest
Conduct peer to peer scientific discussions and maintain a reliable presence with those thought leaders to ensure they have a medical contact within Merck
When needed, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
Provide areas of interest and general information regarding the Merck Investigator Study Program process
Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner
Attend scientific and medical meetings and support development of post-meeting deliverables
Provide clinical and scientific support for Health Systems
A minimum of 5 years of experience in Medical Affairs and/or Virology, Infectious Disease

Medical Affairs Director Resume Examples & Samples

Minimum of 5 years of experience in Medical Affairs and/or Virology, Infectious Disease
Valid Driver's license
75% Travel

Oncology Medical Affairs Director Resume Examples & Samples

Minimum of (5) years’ experience and proven therapeutic competence in oncology and/or immunology
Thorough knowledge of Oncology clinical medicine, pharmacodynamics, pharmacokinetics, pharmacoeconomics, disease management, and medical research including investigator sponsored trials
Knowledge of clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program
Must possess a thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines, laws and regulations relevant to the pharmaceutical industry
Excellent interpersonal communication skills, ability to network, strong personal integrity, collaborative mindset, and a strong patient and customer focus are necessary
Must be able to organize, prioritize, and work effectively in a constantly changing environment, and have demonstrated project leadership abilities
Must possess a valid Driver's License
Field-Based Medical Experience
Clinical Practice and/or Research Experience
Experience in organized healthcare institutions/systems providing experience in developing peer-to-peer relationships with clinicians and scientific leaders

Medical Affairs Director Resume Examples & Samples

Partner with Senior Horizon Medical Affairs Management to advance corporate goals
Leverage clinical and therapeutic qualifications and experience to conceive, develop, and execute projects relevant to advancing the goals of the Medical Affairs Organization at Horizon
Provide therapeutic knowledge or expertise on business development projects and manage Medical Affairs transition process after deals completed
Communicate and partner with key external therapeutic experts (HCPs) to provide and support high level clinical education
Provide support to global sales team and customer base through effective resolution of medical and technical questions which cannot be answered by field service organization
Provide a medical perspective to clinical and regulatory organizations, provide subject matter expertise including the utilization of key clinical data and medical trends to effectively differentiate Horizon’s products and services to marketing teams to develop appropriate collateral materials
Develop and support key clinical and medical affairs strategies in conjunction with commercial counterparts. Provide ongoing and interactive technical and medical expertise to executive on these strategies
Publish in peer-reviewed literature and present at national and international health meetings on topics related to Horizon’s pipeline and commercial products
Interact and present to government, regulatory, and other stakeholders to promote enhancement of the corporation’s reputation
Demonstrate the required “intellectual horsepower” to be a credible expert and develop strong relationships with key opinion leaders, primary and specialty physicians, key professional societies and organizations
Provide expertise in the phase3b/4 development programs and lifecycle management activities for Horizon compounds within therapeutic area as well as business development opportunities
Develop publication plans utilizing internal and external data sources leveraging therapeutic knowledge and data analysis abilities
Deliver background scientific information and specific scientific project training to relevant internal stakeholders (sales marketing, business development, etc)
Lead departmental initiatives regarding support systems and processes to facilitate appropriate conduct and documentation of ongoing project work
Attend and support external medical meetings and conferences
Partner with Horizon Compliance to ensure activities, programs and projects are compliant and consistent with company policies
Medical degree required (MD or ex-US equivalent)
Relevant clinical therapeutic experience preferred; focus in inflammation/immunology a plus
5 + years in Medical Affairs or Medical Affairs and Outcomes Research experience in a pharmaceutical environment
Experience with partnerships and strategic alliances is preferred
Knowledge of clinical trial development and direction
Outstanding oral and written communication skills
Demonstrates strong presence and is a “self-starter.”
Ability to convey, on a peer to peer basis, a therapeutic option in a fair, balanced and highly credible manner
Understands his/her audience; available and able to engage people with varying degrees of scientific background in a meaningful and clear dialogue
Demonstrates ability to relate and work with a wide range of people to achieve results
Able to demonstrate problem solving and risk mitigation skills
Possess a professional, proactive demeanor
Personable, likeable, engaging style that encourages a high morale and teamwork
Performs well under pressure; able to maintain composure in challenging situations
Is able to address issues/concerns in a clear, well-informed manner that engages others in a thoughtful discourse; able to stand up in a polite way and make the case
Exhibits commercial curiosity when evaluating new approaches and solutions
Understands operations and can prioritize for growth
Willingness to work in a multi-disciplinary team environment
Ability to adapt easily to changing work environment; comfortable with ambiguity
Proven outside-the-box thinker and strategist who champions taking calculated risks and embraces new methodologies that drive innovation
Ability to motivate and provide leadership in a growing enterprise; experience building, coaching, and leading teams
Exhibits clear executive presence, is easily recognized as a team leader in a group environment
Exhibits integrity, honesty and a sense of personal accountability
Possesses a well-cultivated self-awareness
Track record of managing conflict resolution with equanimity
Demonstrates ability to serve as corporate spokesperson; capable of representing the company on a global basis in high visibility settings; possess the talent to quickly establish credibility within the business community
Possesses strong listening skills; ability to create win/win solutions; good sense of humor; viewed by subordinates as tough but fair
Proficient in office based computer skills including Word, Excel, PowerPoint, etc

AP Regional Medical Affairs Director, IDV Resume Examples & Samples

Support the development of AP IDV Annual Business Plan
Assist Neuroscience and IDV TA Lead in budget management
Ensure excellent prelaunch preparation for pipeline products
Excellent knowledge of IDV in general with a good knowledge of HIV, Hepatitis, Tuberculosis and Influenza
Sound knowledge of study publication processes and publications
Highly customer and market place focused with an “big picture” orientation
Fluency in additional AP languages an advantage
Awareness of and adherence to Johnson & Johnson Credo values
Medical degree and higher medical qualification essential
IDV experience an advantage
5+ years experience in clinical medicine in an area relevant to the TA
8+ years industry / business experience with a minimum of 3 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
Experience with early pipeline products an advantage
Adaptability and flexibility
Customer & Market Insight

Worldwide Medical Affairs Director Resume Examples & Samples

For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input
Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GCT, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis local medical organizations, and other line functions within GMA&HEOR and external customers e.g., Key Opinion Leaders (KOLs) and patient advocacy groups
Build together with the GBMD a highly influential medical and scientifically based platform
Provide medical scientific input for the assigned program/brand(s)
Support GBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities
Support or deputise GBMD in providing input into brand safety related activities for the assigned program
Deputize for the GBMD in Global Clinical Team (GCT), Global Brand Team (GBT), Clinical Scientific Unit (CSU) and internal decision boards as the Medical Affairs spokesperson
Contribute to talent and career development of MA and Development colleagues like MCLs, SciOps, CTH, CM through active participation in on-boarding, training and mentoring activities. . See job description for further details

Medical Affairs Director Resume Examples & Samples

Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program
A minimum of 3 years’ experience and proven therapeutic competence with biosimilars / biologicals; or analogous experience in Merck US Medical Affairs
Capable of conducting doctoral level discussions with key customers
Business and market knowledge, including quality management
Must possess a thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry
Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel)

Medical Affairs Director Immunology IBD Resume Examples & Samples

Provide input to EMEA business development initiatives for allocated product(s) when requested
Able to accommodate substantial travel
Sign off on Protocols for pan EMEA
Product EMEA MA Publication Strategy
Review and approval of product EMEA Medical Education Programs and scientific materials
Sign off on EMEA Core Medical Information Responses (CMIRs)
Medical review and approval of market research and promotional materials
4 OTHER FEATURES OF THE JOB
Excellent knowledge of the TA in general with a good knowledge of all products within TA
Scientific or Medical degree and higher medical qualification essential
2+ years experience in clinical medicine in an area relevant to the TA
5 + years industry / business experience with a minimum of 2 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
Medical expertise in Gastroenterology and especially in IBD is a must have (could be 5+ years working in this area in the pharma or being an academic Gastroenterologist)
MD, being a potential ETAL Immunology
Product and Therapeutic Area Knowledge and Patient Insight
Medical Strategy Development
Clinical Activities Strategy, Planning and Design
Budgetary Skills and Performance Metrics
Networking and Collaborating
Communication and Interpersonal Skills
Business Tools

Asia Pacific Medical Affairs Director, IDV Resume Examples & Samples

Provide input to AP business development initiatives for IDV when requested
To provide medical scientific and strategic input as requested – e.g. for future cardiometabolic pipeline and/or for established products
Development of AP IDV Medical Plan
Support IDV product launches
In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis) and interpretation
Good knowledge of Drug development process, MAF specific activities and GCP requirements
Good knowledge of study execution, pharmacovigilance
Asia Pacific specificity awareness
Launch experience an advantage
Therapeutic Area Awareness
Organisation and Project Management
Product Development ExpertiseMedical Affairs

Oncology Medical Affairs Director Resume Examples & Samples

Pertinence and quality of scientific recommendations in compliance with current legislation
Quality relationship with leaders and researchers
Compliance with medico-marketing strategy
Compliance with timelines, budget and data reliability
M.D
Experience in: Medico-Marketing in Onco-haematology, Pharmaceutical industry and /or Research and Development
Scientific and medical knowledge
Onco-haematology therapeutic area
Takeda Products
Clinical trials methodology
Competitor products
Legislation on clinical trials (Public health code, Huriet Law, DMOS, MV certification guidelines, etc.)
Health economics (medico-economics, pharmaco-economics)
Oral and written communication methods
Management methods
General information technology tools

Medical Affairs Director Dermatology Resume Examples & Samples

Review and approve the content of EMEA Core Medical Information Responses (EMEA CMIRs) once drafted by the SKM (Scientific Knowledge Management) Product Specialists and Virtual Teams
Work with designated EMEA SKM (Scientific Knowledge Management Product Specialist (s) to integrate and align Medical Information requirements with the EMEA MA Strategy and Plan
Act as expert resource, providing input to responses to complex medical information enquiries
2 SPECIAL REQUIREMENTS
Fluency in English language required
Fluency in additional EMEA languages an advantage
3 ACOUNTABILITIES
EMEA Medical Affairs Strategy and Plan
Line Management of Medical Advisors
Product budget for pan-EMEA MAF activities
Study Specific Summaries of pan-EMEA studies for Annual Safety Reports
Review and approve single country interventional protocols
Final Study Report for EMEA MA Studies
1 ESSENTIAL KNOWLEDGE & SKILLS
In-depth knowledge with at least one product within Dermatology Immunology TA including main competitors
Excellent knowledge of the Dermatology Immunology TA in general with a good knowledge of all products within TA
Good knowledge of EU CTD and GCP requirements
Sound knowledge of study publication processes and publications within the TA
Highly customer and market place focused with an awareness of the importance of business results
Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
Candidate must have a profile that enables to be considered as a strong potential of becoming ETAL in Immunology (Strong business acumen and leadership skills)
2 EXPERIENCE
2+ years’ experience in clinical medicine in an area relevant to the TA
5 + years industry / business experience with a minimum of 2 years’ experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
1 – 3 years project management, team leader or functional line management experience
Industry and Marketplace
Organisational Awareness
Medical WritingMedical Affairs

Medical Affairs Director Resume Examples & Samples

Lead/Chair product Medical team
Co-Chair product brand team with Marketing Brand lead
Responsible for the development and implementation of product medical plans
Product Drug Safety Review Committee representative for US Phase IV program
Manage and oversee product investigator initiated studies program
Partner with Global Life Cycle Leader to ensure product Medical initiatives are communicated and approved according to contractual agreements
Partner with Regulatory Affairs (Cherry Hill) on product NDA annual reports, label updates and FDA communications
Partner with Clinical Science on product clinical development initiatives
Function as a medical expert for Actelion products and provide expertise as needed within and outside the organization
Build strong relationships with key opinion leaders (KOLs) in the therapeutic area of interest and be committed to continuous scientific exchange with KOLs as appropriate in the field and during medical congresses
Act as the Clinical Leader for product Phase IV studies, manage Medical Monitors and ensuring that clinical trials are conducted according to the investigational plan, regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Actelion SOPs
Responsible for ensuring study protocols, amendments, specific sections of study manuals and other documents meeting internal and external requirements
Responsible for managing data from Phase IV clinical program
Responsible for the quality data and scientific presentations, and manuscripts for publication
Develop medical strategy for advisory boards and steering committees
Responsible for scientific data at scientific conferences and other venues
Oversee the development and presentation of scientific data to internal and external audiences
Responsible for the content and quality of the clinical study reports for Phase IV and other regulatory documents as needed
Responsible for the development of the medical plans and timely execution of the plans, both strategic and tactical
Partner and serve as the Medical Lead for necessary cross-functional teams within Actelion US and Global
Collaborate and communicate effectively with Global Medical Affairs and Global Clinical Operations and other relevant teams in relation to assigned responsibilities and programs

Medical Affairs Director Resume Examples & Samples

Minimum of three (3) years experience and proven therapeutic competence in the Disease area
Clinical (patient care) or Deep Research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program
Thorough understanding of the FDA, OIG, HIPPA and other ethical guidelines relevant to the Pharmaceutical Industry
Excellent interpersonal, communication and networking skills
Must be able to organize, prioritize and work effectively in a constantly changing environment
Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access)
Willing and able to travel: 40-60%

Regional Medical Affairs Director Resume Examples & Samples

To provide leadership and technical support to the incumbent’s local / regional Medical and Scientific Affairs team whilst also leading, developing and maintaining the global Medical and Scientific Affairs function
The role is key not only in maintaining the day to day ethical, safety and regulatory aspects of a healthcare business, but also in defending and further developing the healthcare categories and co-ordinating efforts globally and locally to influence change and maximise the opportunities for the business
Drive close collaboration with the R&D, marketing and Regulatory groups to support the local / regional business
The ability to manage a local team whilst focussing on global strategy
An ability to support existing local / regional brands whilst guiding global best practice and seeking out new opportunities for RB
International understanding and flexibility to travel / work across time zones
Experience of guiding teams, managing in a matrix and working with ambiguity
Experience of building and developing high-performing teams and functions
Experience of working with and influencing governmental departments, KOLs and decision makers on an international level within healthcare
A medical degree with broad medical and pharmaceutical / consumer health industry knowledge and experience is preferred
Life science qualifications will be considered when supported by appropriate experience
Knowledge of healthcare regulations, promotional affairs and pharmacovigilance
Broad knowledge of international regulatory frameworks as they relate to medical and clinical requirements for product registration and research
Experience in the Consumer Healthcare sector
Experience of working closely with commercial colleagues and strong understanding of corporate and operational business issues

Regional Medical Affairs Director Resume Examples & Samples

To provide Medical Affairs leadership to the incumbent’s local and regional Medical and Scientific Affairs team globally
Member of the Global Medical Affairs and Clinical Leadership Team
Drive close collaboration with the wider R&D teams, including Global Medical Affairs, Clinical Research, Regulatory, Safety, Quality, Compliance teams and other key stakeholders to support the local / regional business strategies
The ability to manage local teams, magnifying and execute global strategies
Experience of people management, talent development and offering clear strategic guidance
Experience of building teams, managing in a matrix and working at an international level within healthcare
Knowledge of healthcare practices and regulations

Medical Affairs Director NAF Resume Examples & Samples

Lead the Medical Affairs team
Member of the NAF Management team
Develops together with team
Medical Strategy
Medical Education Plans
KOL Developments Plans
MSL activities plans
Data generation and dissemination plan
Local publication plan
MAF projects
Manages MAF budget
Monitors actively MAF performance
Ensures compliance
Collaborates actively with different functions
Education: Medical doctor / Pharmacist
Years of Experience: min 10 years relevant experience
Language: English and preferably Arabic
Location: Cairo, Egypt
Relocation availability
SHAPE: Drive innovation; anticipate and shape industry and market changes to advance health care globally
DELIVER: Deliver results by inspiring and mobilizing people and teams
Experienced leader
Excellent collaboration skills
People management experience
Pragmatic and solutions oriented
Proven people development capabilities
Modern leadership style (less hierarchical)1700158126W

Medical Affairs Director, &I Resume Examples & Samples

Act as full partner to cross functional brand team for brand planning and brand leadership
Ensure execution of agreed medical affairs plan, by direct activities and by leadership of the I&I Medical Affairs team
Manage and ensure appropriate team execution and development, including supervising and providing a medical insight to all training programs, working to agree executional plan and ensuring a proper follow-up
Identify, develop and maintain collaborative relationships with current and future key thought leaders and healthcare stakeholders in disease states of strategic importance to Celgene
Provide regional perspective and imperatives on KOL/stakeholder development
Act as key interface to thought leaders (or external partners) in order to disseminate clinical information, medical education opportunities/materials, and facilitate scientific exchange
Provides medical input to the strategy, planning and review of clinical publications, and review of external clinical research proposals involving the Company products
Evaluate and profile potential investigators/sites to participate in clinical development studies and/or other opportunities for research collaborations utilising Celgene’s pipeline compounds
Assist in the reconnaissance of Market landscape determination and competitive intelligence including therapeutic trends and unmet needs within the appropriate disease states and marketplace
Work cross functionally to help develop appropriate/pertinent tactical activities and resource materials to be distributed upon request to physicians in targeted disease areas
Maintain scientific expertise in Therapeutic Area concordant with current knowledge and practice
Supports general clinical and medical affairs activities involving product evaluation and implementation of franchise business strategies opportunities
Assists in identifying new marketing opportunities
Supports the development of training programs for RML and Commercial colleagues, as appropriate
Participate actively to cross functional teams to conduct global projects
Lead all activities within Spain Compliance requirements. Have the ability to respond to any adverse queries, events or complaints
Responsibility for ensuring I&I medical operations work within our agreed compliance framework and SOPs with final signatory responsibility for the code of practice
Liaise and work closely with the Drug Safety Team who have the key responsibility to report and manage adverse events and risk management
Responsibility for contributing medical / clinical component of HTA submissions and front facing reimbursement and other agencies on medical / clinical matters as appropriate

Medical Affairs Director Resume Examples & Samples

Sales – Travel with the field sales force as needed (primarily in the US, but also abroad) to meet with doctors to present both clinical and economic evidence
Marketing – Understand developments in their assigned specialty and use this knowledge to partner with the marketing team in regards to current and future portfolio decisions
Medical Conferences - Represent SI at national and international meetings by participating in clinical discussions, managing symposia, and fostering education and adoption efforts in the exhibit hall
Medical Science - Master the relevant literature regarding disease pathophysiology, diagnosis and management across their assigned specialty
Advisory Boards - Own and operate clinical advisory boards to ensure the availability of highly qualified, knowledgeable subject matter experts in support of specific business objectives
Scientific Communications – Work closely with the scientific communications teams to develop protocols and publication plans as well as package published evidence in a format that is useful for the sales force - provide medical review for both promotional and non-promotional materials
Clinical Education - Collaborate with the Professional Affairs and Clinical Education team to ensure effective and compliant physician education programs
Strategy – Further develop specialty-specific long term strategy to enable portfolio and call point expansion
Clinical Research - Advise the clinical research team in creating safe, relevant and clinically valuable pre and post market trials and registries
R&D/Pre-Clinical Affairs – Participate in the identification and testing of new devices and materials, which requires a strong scientific orientation
Business Development & Licensing – Identify acquisition and licensing partnerships as well as participate as a member of the due diligence teams
Regulatory Affairs – Understand the complexities of the regulatory approval process, eg be well-versed in the requirements of the European Medical Device Directive and US FDA PMA and 510(k) processes
Quality Affairs/Safety – Have intimate knowledge of quality and safety issues specific to the portfolio
Legal - Serve as a consultant to the legal team to provide clinical information of importance for product liability and intellectual property cases

Worldwide Medical Affairs Director Resume Examples & Samples

For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the Global Medical Affairs Director provides medical scientific input to, e.g.: a. Key activities related to planning, execution and reporting of Global Medical Affairs studies and ensure timely and on budget delivery. b. Develop or contribute to study-related documents (e.g. concept sheets, protocols, case report forms, statistical plan, data analysis plan, study reports, publications). c. Develop/contribute and review presentation materials for study/program-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and external speaker at meetings when required. d. On-going review of clinical study data, final analysis and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team (GCT) members and the GBT (Global Brand Team). e. Act as medical key contact point for assigned Medical Affairs studies
Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., Global Clinical Team, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis Country Pharma Organizations (CPOs), and other line functions within Global Medical Affairs and external customers e.g., Health Care Professionals (HCPs) ,Market Access and Patient Advocacy Groups (PAGs)
Build together with the GBMD Medical Affairs strategy

Worldwide Medical Affairs Director Neuroscience Resume Examples & Samples

For the assigned Medical Affairs studies (Phase IIIB-IV, Post Marketing Surveillance, non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the Global Medical Affairs Director provides medical scientific input to, e.g
Proven ability to interpret, discuss and represent efficacy, statistical and safety data relating to the assigned area
Demonstrated ability to establish strong scientific partnership with key investigators in assigned Therapeutic Area
Medical and/or scientific expertise within a disease area required

Category Medical Affairs Director Resume Examples & Samples

Min. 4 years experience in the Pharmaceutical or Healthcare industry, preferably in a Pharmaceutical/ Consumer Healthcare / FMCH Business with experience in Medical &/or Scientific Affairs
Demonstrated experience and proven track record working as part of a Medical Affairs team within larger complex matrix organization
Demonstrated experience representing an Organization with external stakeholders
Clinical and / or academic research background preferred
Specific Category experience for the aligned Consumer Category E.G. Respiratory
Project specific commercial support – claims support including the creation and approval of Claims Support Summary (CSS) documents and coordinating review / approval of promotional activities
Development and implementation of scientific engagement activities
Contributor to the category/ sub-category medical team meetings
Supporting GSK through engagement with external organizations including Health Authorities, Healthcare Organizations, External Experts etc

Worldwide Medical Affairs Director Resume Examples & Samples

Build together with the Global Brand Medical Director Medical Affairs strategy
Advanced medical/scientific writing and communication skills
Proven ability to work both independently and in a cross functional team setting, including a highly-matrixed environment

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