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Medical Affairs Manager
Il y a 3 mois
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.
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 ongoing 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 crossteam 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 followup 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.
