Senior Medical Writer

Apellis
Published
August 4, 2022
Location
Remote - US
Job Type
Work Setting
Remote / Home-based

Description

Primary objective of the Senior Medical Writer is to provide technical and medical writing support to a variety of regulatory areas including CMC, non-clinical, 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, and IND/IMPD clinical sections 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.
  • Contribute to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical, and regulatory documents for submissions.
  • Assist in the development of the annual medical writing timeline to ensure IB and other
  • pertinent documents are updated as necessary.
  • Assist in the writing of overview and other study related manuals (pharmacy manuals, lab manuals, etc.).
  • Work with CRO’s to ensure study related documents are completed efficiently.
  • Participate in the clinical sub-team.
  • Other duties and responsibilities as required.

Education, Registration & Certification

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

Experience

  • 4-6 years’ experience in a medical writing capacity within the pharmaceutical/biotechnical environment (or equivalent experience).

Skills, Knowledge & Abilities

  • Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
  • 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.
  • Excellent verbal and written communication skills.
  • Experience in a start-up environment preferred.
  • Must be pro-active team player, flexible, and open to change.
  • Some travel will be required, up to 25%.

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!

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