Associate Director, Medical Writing

Position Summary

The primary objective of the Associate Director, Medical Writing is to provide technical and medical writing support to a variety of regulatory areas including CMC, nonclinical, clinical, and administrative submissions.

Key Responsibilities Include

• Work with the clinical and regulatory teams to prepare protocols, protocol amendments, protocol synopses, schematics, 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.
• Ensure 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.
• Drive decision-making about data presentation and document strategies to support advance planning and to meet program objectives.
• Develop and maintain document timelines for assigned projects.
• Contribute to overall project management and cross functional working groups as need to facilitate efficient development and finalization of clinical, nonclinical, and regulatory documents for submissions.
• Assist in the development of the annual medical writing timeline at the indication level to ensure IB and other pertinent documents are updated as necessary.
• Assist in submission planning and serve as lead author of key study reports and Module 2 summary documents. Lead overall document strategy and/or planning activities for submissions when appropriate.
• Manage and mentor junior writers as requested.
• Own and contribute to process improvement initiatives.
• Serve as Medical Writing’s Subject Matter Expert for document types of individual expertise.
• Oversee and/or manage contract writers on assigned projects. Work with CROs to ensure study-related documents are completed efficiently.
• Participate in the clinical sub-team.
• Represent Medical Writing at the indication level.
• Other duties and responsibilities as required.
  
  

Education, Registration & Certification

• Bachelor’s degree; Advanced degree in a relevant scientific/clinical/regulatory field preferred.
  
  

Experience

• 8+ years experience in medical writing capacity within the pharmaceutical/biotechnology environment (or equivalent experience).
• 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.
  
  

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

• 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 https://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 http://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.