Medical Affairs Operations Manager, Contractor

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

The Medical Affairs Operations Manager will be responsible for driving and managing medical affairs activities and logistics, ensuring high-quality and compliant processes and procedures. This role involves coordinating cross-functional teams and vendors, ensuring project timelines are met, and maintaining compliance with regulatory standards. The manager will oversee project management for all US-related medical projects, such as medical education initiatives. Additionally, the manager will assist with budget management and work closely with US Medical Directors, vendors, and cross-functional teams. (Dual reporting to RMDs).

Roles and Responsibilities

1.           Support RMDs in developing and maintaining standard processes and procedures for medical affairs activities, including dissemination of medical information, complaint handling, and review by the Medical Review Committee.

2.           Manage CRM and Kwello processes and reporting of the data.

3.           Establish calendars and project tracking for reports/metrics and updates of relevant documents for projects.

4.           Support activities to further medical affairs initiatives, education, and collaboration across cross-functional partners.

5.           Work closely with the US medical affairs team and other cross-functional partners to assisting in developing and managing the US publication plan and conference plan.

6.           Plan, coordinate, and execute all logistics related to US congress planning, including KOL meetings, group discussions, and ad boards as needed.

7.           Support resource management and logistics for the internal review process of all externally used field medical materials and internal training materials.

8.           Develop and execute internal communication tools for medical affairs activities.

9.           Manage budget, invoice, vendor SOW and tracking.

10.        Manage the Amicus US Medical xChange updates by assisting vendors with MRC submissions and uploads.

11.        Perform administrative support tasks, including scheduling, team meeting coordination, completing and submitting compliance and legal paperwork, and updating dashboards.

12.        Assist in the preparation of reports, presentations, and other documents.

13.        Facilitate communication within and outside of the US Medical Team, and support the development of medical communications and other materials for HCPs.

14.        Organize travel arrangements and event logistics, including managing travel and accommodation for KOLs as needed.

15.        Monitor project tasks to ensure timely and successful project completion.

16.        Perform other duties as assigned.

Requirements

Educational Requirements

•            Bachelor’s degree in health sciences, biotechnology, or a related field; advanced degree (MS, PhD, PharmD, MD) preferred.

Professional Work Experience Requirements

•            3-5 years of experience in clinical research and/or medical affairs project management activities, preferably with a biotech or pharma company.

Experience and Skills

•            Knowledge of and experience with Veeva is a plus.

•            Strong understanding of applicable regulations governing ethical conduct within the pharmaceutical industry.

•            Excellent organizational, communication, and leadership skills.

•            Ability to work effectively in a fast-paced, dynamic environment.

•            Proficiency in project management software and tools.

Other skills/Attributes

•            Demonstrated alignment with Amicus Mission Focus Behaviors.

•            Passion for rare disease and patient focused.

Travel

•            Ability to travel 10-15%.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.  Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.  Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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