Manager, Medical Affairs Job Description
Manager, medical affairs
provides support and systems to maintain standards and ensure compliance with the FDA/MHRA, the GSK Clinical Trial Register and any similar regulatory or VHL processes.
Manager, Medical Affairs Duties & Responsibilities
To write an effective manager, medical affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, medical affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Operationalize vendor selection, budgets, and project timelines
Manage external vendors to deliver on GMA/GDS Collaboration & Communication goals
Manage subteams in workstreams of projects
Oversight of consultants or students supporting the day to day business
Assist in assigned aspects of study management for HCV investigator-sponsored and collaborative trials
Provide scientific expertise into study concepts
Maintain regular contact with investigators to track study progress and publication deliverables
Provide medical and scientific leadership at key scientific meetings involving HCV , AASLD, EASL
Lead and conduct biomarker studies in rheumatology
Communicate and inform on complex scientific and medical information on disease areas in which Sandoz is involved, and on our products
Manager, Medical Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Manager, Medical Affairs
List any licenses or certifications required by the position: PMP, CRO, CMPP, FPX, ABPI, CCPE, PMI, R&D, RMP, ASCP
Education for Manager, Medical Affairs
Typically a job would require a certain level of education.
Employers hiring for the manager, medical affairs job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Medical, Medicine, Pharmacy, Science, Education, Life Science, Life Sciences, Biology, Graduate, Management
Skills for Manager, Medical Affairs
Desired skills for manager, medical affairs include:
National regulatory requirements
Molecular biology and pharmacology
Guidelines
Clinical trial design
FDA regulations
Pharmaceutical industry regulations
Processes
Standards and practices
Timelines
Understanding of clinical development
Desired experience for manager, medical affairs includes:
Acquired university degree in Medicine, Pharmacy, Biology or Chemistry
Native level of Romanian, fluent level of English language (both written and spoken)
Used to interact with scientific audience and marketing & sales people equally
Women’s Health knowledge and experience preferred
Demonstrated high level of competence with MS Office applications and Project Planning software
Describe the type of decisions made by this position on a regular basis
Manager, Medical Affairs Examples
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Manager, Medical Affairs Job Description
Job Description Example
Our company is hiring for a manager, medical affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, medical affairs
- Assist in activities related to Investigator Sponsored Research and Grant requests as appropriate and required
- Ability to perform under minimal supervision as a remotely-located St
- Work with the Country Medical Director to define the Medical Governance strategy to assess, track and mitigate Medical Governance related business risks (including risks identified in risk assessments and/or audit reports) for all core Medical and related activities
- Develop, conduct and monitor management monitoring (MM) activities, as per schedule agreed with all stakeholders
- Cross-functionally integrates and manages resources, including budget and systems, to achieve MAT deliverables
- Collects and communicates performance measures for MAT operations
- Manage TA Sharepoint teamsite, generated presentations, minutes, attendees
- Contribute to the strategy for the growth of specified products or franchises thru medical insight and initiatives
- Assist in creation and review of marketing plans and programs providing medical inputs and being responsible for medical consistency and/or gaps
- Take ownership of key components of the marketing plan
Qualifications for manager, medical affairs
- Doctoral degree (PhD, MD)
- Excellence in English (oral and written)
- Skilled in programming with SAS
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields
- Demonstrated study leadership and management skills
- At least 3 years of experience post graduation/training
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Manager, Medical Affairs Job Description
Job Description Example
Our company is growing rapidly and is hiring for a manager, medical affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for manager, medical affairs
- Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
- Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines
- Build and maintain team repositories
- Assists MSL leadership team in strategic meetings
- Identify and implement KOL development plans
- Provide to local national team analyses of clinical and health economic (incl
- Work in close collaboration with Global Medical Affairs and Clinical Development on the concept, development and implementation of IITs and company sponsored post -registration studies (PhIIIb/IV, IIT trials, and registry)
- Works on local and global projects and initiatives in cooperation with other teams, including Market Access, Marketing, Clinical Development, Regulatory
- Prepares regulatory strategies for medical devices products to determine regulatory pathways to market including FDA "Letter to File" rationales for devices
- Act as liaison for Company with regulatory agencies, with other internal functional departments for new product submission strategy
Qualifications for manager, medical affairs
- Ability to work within a complex environment and takes decisions in uncertain circumstances
- Be a proactive contributor to the cross-functional Neuroscience team in the Benelux
- Support the sharing of knowledge to internal stakeholders through provision of training to help to ensure highest standards of brand/therapy expertise in customer facing teams
- Degree in any medical-related or scientific-inclined courses such as pharmacy, nursing, medical technology and others
- Must possess leadership and organization skills including the ability to communicate motivate, train people, manage resources and make decisions organizational skills and self-confidence
- 8+ years of related experience including 3+ years of sales, clinical, or marketing experience in CRM and EP
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Manager, Medical Affairs Job Description
Job Description Example
Our innovative and growing company is hiring for a manager, medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manager, medical affairs
- Tracking project progress against planned timelines
- Developing and leading a highly motivated and well-trained team with an objective and performance led culture and ensuring skilled staff and services in place to support execution of operational plan
- Working with medical affair director to set up medical objectives, develop medical strategies and tactics, and make medical plans for corresponding disease area
- Aligning with corresponding BAs on the medical objectives, strategies, tactics and plans
- Developing HCP and medical related SOPs according to the requests of Dia Symphony
- Working with medical affair director to develop the KOL medical and scientific collaboration plans in accordance with the medical strategies
- Developing and maintaining a good working relationship with Global Medical and Scientific Affairs for better understanding of global medical strategy and pipeline information, and sharing of best practices
- Medical representation in the review/management of existing Faltering Growth product portfolio and New Product Developments (NPD) projects to ensure clinical relevance is aligned with the commercial needs
- You participate in the creation of an evidence plans for the various sub therapeutic areas Cerebral Palsy, Cardiac
- You are responsible for KOL/stakeholder mapping together with the CBUs and R&D
Qualifications for manager, medical affairs
- Must be proficient in the use of Microsoft office suite, especially Word and PowerPoint
- Knowledge of the Pharmaceutical and/or Vaccine Industry
- 6+ years recognized experience and expertise in medical affairs and teamwork
- Medical qualifications desirable
- 3-5 years pharmaceutical industry experience (Medical Affairs/ Pharmacovigilance/ Clinical Research)
- 5-7 years’ small animal private practice
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Manager, Medical Affairs Job Description
Job Description Example
Our growing company is looking to fill the role of manager, medical affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, medical affairs
- Develops, or is responsible for the development of, regulatory solutions to problems of moderate to intermediate complexity that may affect diverse functional areas of the business or company or unusual complexity in the function
- Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
- Represent specific business areas or geographies as the primary contact, interacting and creating an ongoing, proactive relationship and collaboration with internal scientific, marketing, and engineering colleagues and/or regulatory authorities
- Responsible for overseeing regulatory compliance, development and timely national and international regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
- Reviews staff submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
- Represent departmental function, acting as primary interface with regulators, presenting strategies and negotiating solutions, and may lead and coordinate intra- and inter-company projects
- Interprets, executes, and recommends modifications to operating policies at business level
- Shares experience with most stages of product life cycle and concentrates on new product development and post-market applications of existing products
- Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims
- Acts as an effective regulatory consultant to management and other functions
Qualifications for manager, medical affairs
- Outstanding record of peer-review publication and demonstrated efficacy in medical and scientific affairs activities as they pertain to molecular diagnostic assays and instrumentation
- A wealth of with significant accomplishments both Translational Research and Medical Affairs activities in academia and/or industry
- Extensive experience in integrating diverse inputs from Clinical/Regulatory affairs, Scientific Affairs, Research & Development, and Sales/Marketing a plus
- Successfully directed and led Medical Affairs activities, disease awareness, and medical product training programs within a preeminent diagnostics company which resulted in the commercialization of clinical diagnostic test kits and instrument/reagent systems and adoption of tests in the setting of a results-reporting clinical diagnostics laboratory
- Strong technical background in the diagnostics industry - preferably immunodiagnostics and molecular diagnostics or related fields
- Must have authored and/or co-authored multiple articles and platform presentations that focus on clinical advances in the diagnostic industry and/or immunodiagnostics and molecular
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Manager, Medical Affairs Job Description
Job Description Example
Our company is searching for experienced candidates for the position of manager, medical affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manager, medical affairs
- Delivering of assigned trials within agreed/projected life of trial budget
- Managing the overall contract, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract
- Training, In coordination with other functions, GCO or CRO teams
- Develop and execute a medical strategy to increase Belgian HIV expert’s knowledge and understanding of the benefits and risks of a ViiV HC therapeutic portfolio and collect their insight, in collaboration with Medical Affairs Liaison (MSL) leading to a better use of ViiV HC products
- Develop a local medical strategy for ViiV HC and its portfolio and create, validate and execute a local medical affairs plan in line with this strategy
- Update and train the local ViiV HC team about HIV and about ViiV HC’s medicinal products and perform a thorough medical scientific evaluation and review of the materials used
- Develop, implement, measure medical affairs projects/trials for existing and new products in the assigned countries, in order to support that sales and market share targets are achieved short, medium and long term
- Support implementation of marketing concepts
- Monitor and evaluate changes in the medical and scientific environment (clinical studies, therapeutic trends, etc) respond appropriately and drive actions and business proposals.Responsible for continuously providing scientific medical information and advice to marketing and sales organizations in the assigned countries
- Establish annual medical affairs budgets and monitor periodic financial medical affairs forecasts as required
Qualifications for manager, medical affairs
- Experience in Neurology therapeutic area will be a distinct asset
- Experience filing submissions for medical devices in the US and International markets, 510(k)s, Technical Files, Summary Technical Documents (STED)
- Minimum 5 years of relevant experience working within the pharmaceutical industry, exposure to the common interaction-points between medical and commercial partners
- Solid business analysis skills with experience integrating primary and secondary data to drive insight
- Strong communication, influence and presentation skills, both written and verbal
- Conduct ad hoc analysis of primary and secondary data to inform strategic decisions understand effectiveness and quality of various medical education and clinical operations investments