Manager, Medical Affairs

Job Description:

Amylyx is looking for a Medical Affairs Manager who will providing support to the Medical Affairs to achieve short- and long-term medical objectives in alignment with the overall business strategy. This individual will be an integral member of the Amylyx Medical team, supporting ongoing and new medical initiatives including scientific exchange, medical education, publications, congress activities, advisory board meetings, medical information, and integrated evidence generation. The Manager will have the unique opportunity to be exposed to and gain experience in roles across the Medical Affairs function, taking on increasing responsibility in areas of interest over time. The role will report to the Director, Medical Affairs.

RESPONSIBILITIES

• Collaborate with the Director of Medical Affairs to deliver key medical communications activities in assigned areas including, but not limited to:
  • Publications: Oversee and execute the strategic publication plan and scientific communications for congresses (abstracts, posters, oral presentations)
  • Scientific Platform: Develop and continuously update for assigned disease state(s)
  • Advisory boards: Support development of materials and content; ensure medical accuracy and appropriate review/approval and insight documentation
  • Medical Information: Lead the day-to-day operations of the in-house medical information function, including acting as a main point of contact to address requests, develop medical information content and ensure appropriate review/approval
  • Scientific Exchange Materials: Support the development and dissemination of scientific exchange materials, including reactive and proactive slide decks and print pieces
  • Congress Planning: Partner with cross-functional congress planning team to ensure seamless execution of pre-, during, and post-congress activities
  • Promotional Material Review: Provide timely and accurate reviews of promotional materials for assigned areas in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs
• Drive the successful completion of tactics supporting the Medical Affairs and Market Development Strategy for assigned programs, including:
  • Literature Reviews: Critically evaluate the published medical and scientific literature related to assigned therapeutic areas and relevant competitive products
  • Data Generation: Manage review of grant and investigator-initiated research proposals
  • Lifecycle Management: Support the development of integrated evidence generation plans, expanded access programs, and participate in lifecycle management support activities
  • HCP Mapping and Key Opinion Leader Identification: Support identification and profiling of key HCPs in relevant therapeutic areas

REQUIRED QUALIFICATIONS

• Advanced scientific degree (PharmD, MD, or PhD)
• 2-3 years of clinical, scientific/research, or industry-related experience or equivalent
• Knowledgeable of US and international regulations, requirements, and guidance associated with scientific publications
• Experience supporting and/or leading research projects and publications processes
• Ability to understand, critically analyze, and summarize complex scientific and medical data
• Ability to work in fast paced, collaborative, cross-functional teams.  High sense of urgency and commitment to excellence in the successful achievement of objectives.
• Excellent planning and organizational skills. Ability to manage multiple projects simultaneously, think critically, and prioritize as needed based on timelines
• Excellent verbal/written communication, listening, and presentation skills
• Proficiency in Microsoft Office platform and resources (i.e., Word, Excel, PowerPoint) and virtual platforms
• Basic knowledge of drug development process, clinical trial design, results and methodology, regulatory and compliance requirements is desirable
• Preferred experience and knowledge in the following areas: rare disease, neurology, and/or endocrinology
• Prior medical affairs, medical communications, publications and/or KOL management experience preferred
• Flexibility to travel 20% of time, including international travel

WORK LOCATION AND CONDITIONS

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Delaware, Hawaii and Kansas.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

This job description is not intended to be all inclusive. Employee may perform other related duties as delegated to meet the ongoing needs identified by the company.

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