Medical Affairs Evidence Generation Manager

3 weeks ago

Waltham, Massachusetts, United States Apellis Full time
Job Title: Medical Affairs Evidence Generation Manager

Job Summary:

The Medical Affairs Evidence Generation Manager will play a key role in the Global Medical Strategy and Evidence Generation team, working closely with Medical Affairs and cross-functional stakeholders to execute project management and operational activities for key initiatives of the global strategy and evidence generation plan for systemic pegcetacoplan.

Key Responsibilities:

  • Evidence Generation Operations:
    • Project Management: Lead project management and day-to-day operations and tracking of ongoing evidence generation efforts, including phase IV and observational studies, according to the Global Evidence Generation Plan.
    • Study Level Responsibilities: Ensure evidence generation projects are conducted in compliance with relevant SOPs and applicable internal, external, and regulatory requirements.
  • Publication and Strategic Operations:
    • Publication Operations: Manage medical writing vendors to ensure execution of publication plans in accordance with timelines and budget.
    • Strategic Operations: Provide operational and planning support for medical conferences, advisory, and scientific steering committee meetings.
  • Education, Registration & Certification:
    • Must have a bachelor's degree.
    • A master's degree in a health-related or life sciences field with PMP certification is preferred.
  • Experience:
    • 3+ years of project and/or vendor management experience in pharmaceutical/biotechnology supporting cross-functional teams.
    • Vendor management experience.
    • Experience in interventional, non-interventional, or observational clinical study operations or medical affairs is preferred.
  • Skills, Knowledge & Abilities:
    • Strong project management and tracking skills, including demonstrated ability to manage multiple projects.
    • Proficiency in project management software, Microsoft Office suite, OneNote, and Box.
    • Experience in Datavision is preferred.
    • Excellent oral and written communication skills, including presentation and facilitation.
    • Strong cross-functional collaboration skills.
    • Ability to work independently and with flexibility to handle workflow in a fast-paced environment.

Travel Requirements:

Some travel will be required, up to 30%.

Benefits and Perks:

Apellis offers a great benefit package, including health insurance with full premium coverage, 401K with company match, paid time off (PTO), long-term disability insurance, life insurance, and more. Visit https://www.apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit https://www.apellis.com/ or follow us on Twitter and LinkedIn.

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state, or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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