Senior Medical Writer (Regulatory)

Highly Competitive Salary
  1. Permanent
  2. Medical Communications, Medical Writing, Media & Publishing
  3. United States
Washington Township, USA
Posting date: 08 Aug 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Medical Writer (Regulatory) for an innovative biotech company located in New Jersey.

Must be eligible to work in the US.

Job Responsibilities:

  • Medical writing to include but not limited to annual reports, Investigator's Brochures, protocols/amendments, CSRs, manuscripts, regulatory submissions that reference/summarize clinical data.
  • Researches, writes and edits pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.
  • Prepares clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration and other regulatory authorities worldwide, for publication and/or presentation.
  • Assists in the development of formats and guidelines for clinical documentation.
  • May prepare scientific manuscripts, abstracts and posters.
  • May also support clinical research associates and medical doctors in clinical protocol development.
  • Keeps abreast of professional information and technology through conferences.
  • Perform literature reviews and solicit input from medical, statistical and operational resources as necessary to support document content.
  • May assist other departments (regulatory, research) with writing projects on an ad-hoc basis.
  • Ability to assist with other clinical science activities (review of data to ensure cleanliness/appropriateness for analysis, QA of statistical output, and data compilation to support data summaries/presentations) considered a plus.

Skills and Requirements:

  • Strong medical writing skills: takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
  • Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
  • Knowledge of and experience in clinical development.
  • Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
  • Ability to collaborate in a matrixed environment and work as part of a cross-functional team.
  • Ability to develop collaborative working relationships with contracted vendors.
  • Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
  • BA/BS/RN degree or equivalent in a scientific or health care field required. Advanced degree (MS, MPH, PhD, or PharmD)
  • Preferred 3-5 years medical writing responsibilities
  • Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.
  • Experience in inflammatory/ immunologic diseases preferable.

If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.