Medical Affairs Director Job Description
Medical affairs director
provides expert medical and scientific support to multiple departments and interdepartmental teams including Medical Affairs, Health Economic Outcomes Research, Publications, Clinical Development, R&D, Regulatory, Global Strategic Marketing, EU/ROW Regional Marketing and Market Access.
Medical Affairs Director Duties & Responsibilities
To write an effective medical affairs director job description, begin by listing detailed duties, responsibilities and expectations. We have included medical affairs director job description templates that you can modify and use.
Sample responsibilities for this position include:
Represent department in meetings with regulatory agencies
Provides leadership for the Medical Affairs Strategy department, including all activities undertaken by CD/MA Medical and Clinical Directors and medical personnel in the global arena
Actively participates in advancing and communicating management leadership philosophy and agenda to the CD/MA organization
Drives medical affairs strategies related to the generation and dissemination of data, supporting overall scientific and business strategy
Oversees CD/MA medical and clinical directors in their direction, conduct and interpretation of clinical trials and research
Interacts with and coordinates appropriate scientific and medical activities with internal stakeholders
Supports the team in opinion leader development for key products and therapeutic areas
Ensures high quality and efficiency of the CD/MA medical affairs strategy team, and that agreed upon timelines for projects are met
Develops and maintains a strong team that is accountable for the day to day management of their products, ensuring a high quality of the CD/MA organization
Participates in managing the CD/MA department budget and financial planning
Medical Affairs Director Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Medical Affairs Director
List any licenses or certifications required by the position: MD, CMPP, ABPI, M.D, FEMA, MV, DMOS, ASQ, BU, PMP
Education for Medical Affairs Director
Typically a job would require a certain level of education.
Employers hiring for the medical affairs director job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Doctorate Degree in Medical, Medicine, Science, Oncology, Life Sciences, Education, Pharmacy, Medical School, Sciences, Graduate
Skills for Medical Affairs Director
Desired skills for medical affairs director include:
Clinical trial methodology
Microsoft Office Suite
Pharmacoeconomics
Study execution
Clinical medicine
Disease management
Managed market environment
Medical research
EU CTD and GCP requirements
Global Medical Safety and regulatory affairs
Desired experience for medical affairs director includes:
MD required with more than 5 years of advanced medical/scientific knowledge in Oncology/Hematology preferred
MD or PhD with unique knowledge for successful clinical program development and execution required OR an MD with specialty with board certification
Experience with dermatology is a strong plus
Ensures appropriate staffing, training and development in order to meet business needs and deliver quality services
Ensures compliance with the highest clinical research and ethical standards
In-depth experience of operating in the international arena
Medical Affairs Director Examples
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Medical Affairs Director Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of medical affairs director. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical affairs director
- Develop global medical affairs strategy and plans for the assigned products based on prioritized regional needs
- Provide single Medical Affairs voice in creation of product development and LCM strategies, plans and trial design from phase IIa through phase IV
- Responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas
- Lead medical affairs activities to develop collaborations and gain insights from external stakeholders and experts
- The GMAD will be an active member of the Product Development Team (PDT) and will lead a global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the PDT
- Responsible for the development and execution of the global publication plan review and approval of publications
- Support development of the company risk management strategy
- Responsible to ensure all global activities follow J&J Compliance principles, eg
- Responsible for developing a robust evidence generation plan for products within the Advanced Diabetes care portfolio
- Responsible for authoring study synopses and partnering with the CCD, overseeing the completion of robust study protocols in an efficient manner
Qualifications for medical affairs director
- Proficiency in accessing data sources of differing complexities required
- Budget Management - ability to develop an operating budget to monitor and control expenditures
- Solid experience in Medical Affairs (affiliate or international medical affairs preferred)
- Understands the impact of communication messages on others
- Builds actively on long-term relationships, both internally externally across different functions
- Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language
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Medical Affairs Director Job Description
Job Description Example
Our growing company is looking to fill the role of medical affairs director. 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 medical affairs director
- Responsible, as Study Responsible Physician, for the writing and the quality of the Study Specific Safety Summary for pan-EMEA studies, per ASR guidance and the J&J template
- Provide clinical input to CCDS or SmPC update process and where appropriate ensure development and approval of clinical overview
- Lead the development and alignment of product life cycle management strategy and tactics to define and prioritize future clinical trials for investment
- Ensure the integrity of all scientific activities
- Ensure and promote professional/compliant interactions with internal and external stakeholders
- Provides oversight and guidance to country medical colleagues about country medical affairs activities relevant for MSD products
- Typically does not supervise employees but must be able to influence in a matrix environment
- Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to Derm therapeutic area or disease specific information
- Is member of the Publication team
- Reviews investigator sponsored research (ISR) proposals in the TA
Qualifications for medical affairs director
- Proven capabilities with clinical trial design and ability to interpret, critique, and to present study results are essential
- Experience in working with KOLs to design clinical studies is also essential experience
- Experience in partnering with R&D and corporate clinical study groups is also highly desirable
- Experience and established relationships with Diabetes KOLs are required
- Clinical experience managing patients is also preferred
- Excellent presentation, interpersonal and communication skills (both verbal and written) are expected
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Medical Affairs Director Job Description
Job Description Example
Our innovative and growing company is hiring for a medical affairs director. 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 medical affairs director
- Closely collaborate with MSL director GI and MSLs in the field to gain and collect scientific insight
- Assist in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
- Provide scientific and technical support for assigned products
- Leads and directs statistical planning and strategy development for an assigned therapeutic area (TA) focusing on the GMA related activities in the assigned TA
- Provides strategic medical practice input to the Product Development Teams to ensure that appropriate phase IIIb and Phase IV studies are planned and executed to provide practice relevant data on the marketed products
- Establish and maintain relationships with Key Opinion Leaders (KOLs) in respective therapeutic area to establish strong scientific presence in the practicing and academic communities
- Develop programs and activities appropriate to launch designated products, including training materials, standard responses (inc. medical information), product monographs, data updates, rep memos and other materials as required
- Function as central company point of contact in coagulation for the medical community
- Work with the Dermatology Therapeutic Area Lead, other individuals within Medical Affairs and other functional areas within J&J, as necessary, to facilitate research expanding the knowledge of all Janssen marketed products for immune disease
- Collaborate with external investigators and thought leaders
Qualifications for medical affairs director
- Typically 10+ yrs experience in the pharmaceutical industry or equivalent
- MD preferred, or PharmD/PhD in life sciences for candidates who have significant Medical Affairs experience
- At least five years’ Medical Affairs experience in a role in a pharmaceutical company/biotech company/clinical research organization, of which at least 3 years are focused in Diabetes
- Broad experience in development and management of physician relationships
- Strong strategic, problem-solving, risk mitigation skills
- Must have experience with applying legal and regulatory guidelines in drug development, including knowledge of OPDP promotional regulations, and CDER/CBER regulations as they relate to drug approvals
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Medical Affairs Director Job Description
Job Description Example
Our company is looking to fill the role of medical affairs director. 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 medical affairs director
- Present at training courses, sales conferences, regional meetings, to develop high level of medical knowledge within the organization
- Medical Interactions/Scientific Exchanges-including responding to unsolicited requests for off-label information in accordance with FDA guidance
- Plan, review, approve required documents from various departments for filing of required information to FDA, including
- Work with the relevant disease area Life Cycle and Business teams including Life Cycle Leaders, International Business Leaders, and International Product Managers to support commercialization of Microbiology products
- Provide scientific input to support the various milestones in the design control process (responsible for publication strategies and providing input into customer requirements, product design
- Serve as a core International Business Team (IBT) member
- Provides support and leadership of RMS scientific activities for product launches and post-marketing support through scientific material development, speaking events and publications
- Serves as subject matter expert to Microbiology on clinical and laboratory-based and molecular diagnostics issues
- Key scientific liaison between the IBT and affiliates for scientific communication
- Liase with regional Medical & Scientific Affairs representatives
Qualifications for medical affairs director
- Interact with internal Pharmacovigilance group in the review of post-marketing safety-related occurrences
- Background / experience with endocrinology and/or hepatology and/or gastrointerology a definite plus
- Working knowledge of general medicine and drug therapy, including pharmacology, toxicology, trial methodology and clinical pharmacology
- Orphan diseases knowledge/experience a plus
- Knowledge of regulatory requirements for submission and experience interacting with regulatory agencies will be beneficial
- Legislation on clinical trials (Public health code, Huriet Law, DMOS, MV certification guidelines)
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Medical Affairs Director Job Description
Job Description Example
Our growing company is hiring for a medical affairs director. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for medical affairs director
- Provide Urology related scientific input to internal stakeholders across multiple functional areas including Marketing and Sales, Health Economics, Medical Information, and the Medical Science Liaisons
- Serves as medical representative on Risk Evaluation teams
- Additional routine or ad hoc duties as assigned based on ongoing needs assessment
- Maintains responsibility for overall knowledge management and developing /maintaining structure and processes to support effective communication of clinical business related information to the field and from the field into Horizon corporate
- Ensure RMD resources (training and materials) are made available to RMDs in a timely manner and are accurate, current and compliant with The Global Manual policies
- Establish and maintain expertise of adult learning principles and practices
- Ensure cross-functional communication and partnership in execution of tasks supporting strategies for marketed and pipeline assets across business units
- Monitors changes in technology to evaluate RMD equipment and software to ensure maximal efficiency in the field
- Coordinates management team activities, including regular communication process, reports (quantitative & qualitative), key initiative development and tracking timelines, ND/RMD allocation and assignment to support medical meetings, congresses, and internal corporate meetings, etc…
- Manages external vendor/contract relations including obtaining SOWs, negotiation of proposals per the direction of VP Global Clinical Sciences & SVP Medical Affairs
Qualifications for medical affairs director
- 10+ years’ experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies
- Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, start-up, execution, analysis and reporting) with at least 5 years industry experience at local, regional and/or global level
- Effective management skills to optimize resources and budgets to meet business needs
- Ability to provide medical expertise to ensure successful product launches across functions
- A minimum of 5 years of experience in the management and conducting of clinical studies (Phase II-III)
- A minimum of 3 years of experience in the management and conducting of phase IV studies (within medical affairs)