This job is currently Archived,
Medical Affairs Specialist Emeryville United States,
Posted on : 19 May 2017
PRIMARY PURPOSE OF POSITION:
- The Medical Affairs Specialist will administer company s medical education grants process, including optimizing policies and procedures, facilitating the grants committee, and administering responses and contracts.
- The Medical Affairs Specialist will also administer the medical materials approval process, including optimizing policies and procedures, administering the technology system, facilitating committees, and managing use and archival of medical materials.
- The Medical Affairs Specialist will assist with other administrative duties as required.
MAJOR DUTIES OF POSITION:
- Understand and continually improve upon company policies and procedures related to collection and adjudication of medical education grant requests
- Administer the technology portal used to collect and adjudicate medical education grant requests
- Schedule and facilitate Medical Education Grants Committee meetings, collect and distribute meeting minutes
- Process the adjudication of medical education grants, including communications with the requestor and internal communications
- Process contracts and other administrative tasks for approved medical education grants
- Provide status and analytical reports as requested to Senior Director of Scientific Communications and other internal stakeholders as requested on medical education grant requests
- Follow up with medical education events supported by company to ensure alignment with identified educational gaps and reconciliation of grants
- Serve as Medical, Regulatory and Legal process (MeRL) Coordinator
- Understand and continually improve upon company policies and procedures related the development, review, approval and use/archiving of medical materials
- Administer the technology portal used for medical materials development and use/archiving
- Drive medical materials through the life cycle of each document across four ophthalmologic therapeutic areas
- Schedule and facilitate MeRL Committee meetings, collect and distribute meeting minutes and action items
- Track life cycle of medical materials to ensure needed updates or expiries
- Assist with logistical planning for company sponsored medical education events, including scientific symposium and scientific open houses.
KNOWLEDGE AND SKILL REQUIREMENTS:
- BS required, preferably in the life sciences
- Minimum of 3+ years previous relevant industry experience
- Facility with many types of technology solutions, preferably as applied in the life sciences; including but not limited to: Vision Tracker, MedComms, DataVision, Tableau, and CRM
- Strong organizational skills and ability to follow through with attention to detail
- Demonstrated history of securing cross-functional input and participation at various levels of a culturally diverse organization
- Exemplary interpersonal communication skills, both oral and written, and strong meeting facilitation skills
- Knowledge, understanding and adherence to global regulatory guidelines (e.g. FDA, EFIPA, PDMA, JPMA, PhRMA, etc.)
- Understanding of the regulatory and compliance environment related to Medical Affairs activities
- This role has global scope.
- This requires skilled collaboration and cultural awareness as well as high technical intelligence.
- The Manager will interface with various levels of internal stakeholders in a highly matrix environment.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed are representative of the knowledge, skill, and/or ability required.
- The individual may be asked to travel very occasionally (<5%).
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
- The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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