Senior Manager, Medical Writing
Proclinical is seeking a Senior Manager, Medical Writer for a leading pharmaceutical and biotech located remotely. As the Senior Manager, you will serve as the medical writing Lead contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and other regulatory submissions documents.
- Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
- Plan, coordinate, and oversee clinical study registration and results posting in various clinical trial disclosure platforms.
- Plan and coordinate timelines to ensure timely completion of clinical writing projects.
- Manage timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.
- Lead significant workstreams that involve work across departments or with external vendors.
- Provide support for QC of complex clinical documents.
Skills and Requirements:
- Minimum of bachelor's degree or equivalent in scientific or medical discipline; Advanced degree preferred.
- Minimum of 6-8 years medical writing experience with at least 5 years of pharmaceutical or biotech experience required.
- Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
- Experience producing high quality clinical and regulatory submission documents.
- Strong project management and organizational skills.
- Strong organizational/prioritization skills for the management of multiple concurrent projects.
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches.
- Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes.
If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-388-1650 or firstname.lastname@example.org.
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.