Senior Manager, Medical Writing - Remote

Highly Competitive Salary
  1. Permanent
  2. Medical Communications, Medical Writing, Account Management
  3. United States
Cambridge, USA
Posting date: 20 Oct 2020

Proclinical is currently recruiting for a Senior Manager of Medical Writing with a global biopharmaceutical company located remotely. As the Senior Manager, you will work with global colleagues across R&D to ensure high quality documents are produced in the timeframe provided.

Job Responsibilities:

  • Write and edit clinical regulatory documents companywide for sense, clarity, accuracy, and effectiveness.
  • Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives.
  • Provide writing support for a wide range of documents, including investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
  • Work with the lead writer to create, manage and communicate the document timeline to ensure all reviews are completed in predetermined timeframe.
  • Ensure that documents comply with International Conference on Harmonisation guidelines, company SOPs, and Good Clinical Practices.

Skills and Requirements:

  • BA/BS or higher required
  • At least 4 years of writing experience in the pharmaceutical industry
  • Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
  • Experience with a variety of regulatory and clinical documents
  • Experience in a matrix environment
  • Excellent written and oral communication skills and demonstrated problem-solving abilities
  • Ability to handle multiple projects and short timelines
  • Ability to work cooperatively with colleagues in a wide range of disciplines
  • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-223-4835 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.