Position Summary:

Apellis is seeking a Senior Director, Medical Writing (MW) to lead the MW, editing, and clinical publishing groups in support of a variety of regulatory areas including CMC and non-clinical, but primarily clinical. This role reports directly to the SVP, Development Operations.

Key Responsibilities Include:

• Responsible for managing the MW department budget, strategic planning, and overall operating strategy for the MW department.
• Responsible for ensuring the MW department is adequately staffed to support all corporate objectives.
• Collaborate cross-functionally to oversee the preparation of protocol synopses, protocols, protocol amendments/addenda, study reports, investigator brochures, annual safety reports, IND/IMPD clinical sections, Module 2 summaries, briefing books, regulatory responses, and other documents as necessary in CTD format under strict timelines.
• Responsible for inspection readiness activities for the MW group.
• Responsible for Apellis's editorial standards and style guide. Oversee efficient formatting of documents, ensure a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier.
• Responsible for the data verification/quality review process for documents developed by the MW team.
• Oversee overall project management of document timelines for cross functional working groups to facilitate efficient development and finalization of clinical, regulatory, and safety documents for submissions.
• Oversee management, professional development, training, and performance of all MW staff.
• Oversee the document publishing group to facilitate publishing of clinical, nonclinical, and CMC documents and an efficient hand-off to the regulatory submissions group.
• Manage the MW vendor selection process and maintain regular communication with selected vendors.
• Point of escalation of issues related to the document development process.
• Other duties and responsibilities, as required.

Education, Registration & Certification:

• 12+ years' experience in a medical writing capacity within the pharmaceutical/biotechnical environment (or equivalent experience).

Kills, Knowledge & Abilities:

• Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, regulatory, and medical terminology preferred.
• Detailed knowledge of the requirements for preparation of key clinical, nonclinical, and regulatory documents for INDs, CTAs, BLAs, and annual reports preferred.
• Experience in rare disease and/or ophthalmology preferred.
• Experience in a start-up environment preferred.
• Experience managing and mentoring employees preferred.
• Comfortable with ambiguity and resilient in the context of a rapidly changing, highly innovative environment.
• Highly collaborative with strong problem-solving skills.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit 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 or follow us on and

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.