Description:
The Associate Director/Director, Medical Affairs Strategy will manage the medical affairs strategic plans for both internal company programs and external facing interactions. They will provide specialist medical & scientific strategic and operational input into core medical affairs activities. Internally, the Associate Director/Director will work cross-functionally with many different internal and external stakeholders to execute the plan of action for PWS. This role reports directly to the Head of Medical Affairs Strategy.
RESPONSIBILITIES:
- Support annual medical planning for PWS; work closely across Medical Affairs functions to develop and monitor execution of overall medical strategy and Medical Affairs tactical plans.
- Provide therapeutic area expertise, medical support, and scientific insights to inform and align cross-functional strategic plans, as appropriate.
- Serve as medical reviewer and expert on promotional and medical review committees.
- Establish and maintain relationships with important opinion leaders, medical societies, and other external partners to gather insights and inform medical strategies.
- Lead and participate in advisory boards, symposia, and scientific conferences to gather insights, disseminate clinical data, and enhance awareness of PWS.
- Stay up to date with scientific advancements, competitor activities, and industry trends to inform strategic decision-making.
- Contribute to the development and standardization of key Medical Affairs policies, processes, and internal guidance documents.
- Ensure compliance with all relevant laws, regulations, and industry codes of conduct in the execution of medical affairs activities.
- Other duties as assigned.
QUALIFICATIONS:
- Advanced medical/scientific degree (MD, PhD, Pharm D, NP/PA) with a minimum of 5-7 years of experience in the Pharmaceutical or Biotech Industry within Medical Affairs.
- Prior launch experience, in orphan and/or specialty is a plus.
- Ability to think strategically and translate that strategy into an actionable work plan.
- Excellent communication and interpersonal skills, with the ability to engage effectively with internal and external stakeholders.
- In-depth knowledge of the regulatory environment and compliance requirements related to medical affairs.
- Experience in PWS or in orphan disease preferred.
- Exceptional analytical, organizational and scientific/medical presentation skills is required.
- Ability to work successfully in a dynamic, fast paced, team-oriented environment.