Senior Manager, Medical Writing - Remote
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.
- 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 email@example.com.
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.