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Amicus Therapeutics seeks a Medical Affairs Manager for a 6-month contract to support the 2025 International Medical Plan in Fabry disease. The role involves leading scientific engagement, ensuring compliance, and collaborating with global teams to enhance medical affairs activities. Ideal candidates will have experience in rare diseases and strong stakeholder management skills.
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Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
Position Summary
This contractor position is being hired to support the execution of the 2025 International Medical Plan in Fabry disease. The role will ensure continuity of high-quality medical affairs activities across International regions, supporting both strategic and operational priorities.
Key Responsibilities
Scientific Engagement & Data Dissemination
Lead the design and execution of advisory boards and medical education events.
Support insight gathering through scientific meetings, conferences, and direct HCP engagement.
Develop scientific slide decks to support reactive engagement by affiliate medical teams.
Medical Collaboration & Communication
Act as a liaison between global medical affairs, affiliate medical teams, and international stakeholders.
Organize and lead medical meetings such as journal clubs, International literature reviews, and monthly international medical calls.
Medical Review & Compliance
Provide ABPI review and oversight of promotional and non-promotional materials.
Serve as the medical lead in the Copy Review Board (CRB) process and ensure alignment with international commitments.
Ensure compliance with ABPI/IPHA codes, internal SOPs, and local regulations.
Medical Information & Operational Support
Support medical information processes and congress medical activities.
Ensure appropriate escalation and documentation of adverse events and pregnancy reports, in accordance with pharmacovigilance requirements.
Systems & Tools
Navigate and lead medical review using Veeva Vault for all material and CRB processes.
Medical Training
Create and deliver effective Medical training and clinical updates
Develop slide decks for training activities and for the support of key customers
Demonstrate expert knowledge of Amicus’ and competitor products and activities
Clinical Trial activity
Contribute to the management of Investigator Initiated Studies (IIS) and collaborative studies
Provide strategic input into the development and execution of local clinical trials, IIS activities and publication plans
Key Deliverables / Measurable Goals
Lead the execution of at least two major scientific events (advisory boards or educational meetings) by end of contract.
Deliver a complete set of Fabry scientific engagement materials (slide decks, FAQs) to affiliates for local use.
Maintain continuity of standing activities, including journal club, monthly international medical calls, and literature summaries.
Provide timely and compliant medical review and signatory oversight for all relevant CRB submissions and initiatives.
Requirements
Educational Background and Professional Work Experience
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