Medical Affairs Manager
il y a 3 semaines
Overview:
As part of the medical affairs team, the Medical Affairs Manager will be responsible for the support of both internal and external facing Medical Affairs activities. External people includes authors, KOLs and commercial partners. The position requires a strong medical/biological background with both clinical and research experience. The position will work cross-functionally with the organization.
**Responsibilities**:
- Develop and continuously maintain the highest scientific and medical expertise in the field of contraception and/or menopause, and adjacent specialties, especially in areas which affect the company.
- Maintain a high level of knowledge of and appropriately implement current local pharmaceutical regulation in conjunction with Regulatory Affairs and ensure implementation of company policies and procedures.
- Attend appropriate national and international meetings and congresses for personal education and engagement and scientific exchange with the medical and scientific community.
- Support the development and drive implementation of a local Medical Affairs Plan and strategy, to support best clinical practice and the overall corporate objectives.
- Ensure that accurate and comprehensive scientific information concerning our products is available to decision makers and healthcare providers.
- Work closely with partners to identify and address staff training needs. Conduct and provide medical leadership to training programs for the commercial teams and other functions.
- Coordinate the timely and appropriate response to internal and external Medical Information enquiries, utilizing global medical information resources and in line with local regulatory requirements.
- Drive the identification, development, and alignment with Key Opinion Leaders, other important customers and stakeholders, including professional organizations.
- Deliver quality medical education presentations in a variety of settings and obtain valuable feedback that can be disseminated throughout the organization e.g. Staff Meetings, Round Tables.
- Ensure timely and informative scientific/medical exchanges with external customers and internal partners, which accurately reflect scientific data, in accordance with compliance policies and procedures as well as with legal and ethical standards.
- Support the implementation of medical affairs practices to assess new indications, the treating community, patient pathways, diagnostic practices, and management strategies in relevant disease areas.
- In conjunction with clinical operations support clinical study feasibility and effective study implementation and on-going management of company sponsored trials, including disease registries.
- Act as a point of contact for investigator sponsored research projects.
- Support medical education programs on a regional and national level: Identify speakers, discuss scientific content with speakers, and review slides in order to ensure compliance with policies, laws and regulations.- Facilitate all elements of publications activities, including coordination of internal, collaborator and author stakeholders. Includes facilitation of meetings with cross-team functions and potential external partners, as appropriate. o Liaise and facilitate interactions and provide direction and guidance to vendors supporting the team. Act as the point person for interacting with the selected vendor, (typically on a weekly basis).- May include support of the development of congress plans, and collation of scientific expert activities, as well as supporting related scientific activities, such as scientific narratives, and mechanisms of action.- Ensure all publication activities adhere to SOPs (which includes ICMJE and GPP3), which includes filing, archiving, and timely communications and follow-up with all key stakeholders.- Ensure update of data dissemination plan at periodic intervals as deemed necessary.- Maintain timelines and facilitated milestones to ensure timely delivery of publication material to scientific congresses and/or journals.- Provide updates of scientific publication activities on a regular basis and/or as directed. This may include provision of updates in PowerPoint, word, or other formats.- Participate in timely submission of regulatory documents or other medical affairs documents as needed.
Qualifications:
- Relevant scientific degree essential (MD, PhD or PharmaD).
- Minimum 2 years Biotechnology/Pharmaceutical field experience.
- Fluent in English both spoken and written.
- Prior experience as a medical affairs manager is a must.
- Proven track record of relationship development in the industry.
- Proven ability and experience to present complex scientific data.
- Prior exposure to complex matrix organizations or experience working as part of a virtual team is a plus.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
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