At Synterex, we forge lasting and meaningful relationships that flex with the dynamic nature of science and technology.
Manager, FSP Medical Writing
Location
Massachusetts
Posted
4 days ago
Salary
$16.2K / month
Job Description
Job Requirements
- Undergraduate degree in a scientific or health-related field required
- Minimum 5 years of clinical research/drug development experience in biotech, pharmaceutical, or contract research organization (oncology experience a plus).
- Equivalent experience in a related medical field is acceptable.
- Experience managing diverse teams preferred
- Team-oriented, self-motivated, assertive, self-confident, and capable of working under minimal supervision
- Ability to assess and coordinate resources and work effectively across multi-disciplinary work teams
- Exceptional communication and interpersonal skills
- Excellent organizational and project management skills to coordinate resourcing across multiple projects
- Experience with regulatory documents (Module 2 summaries, IND, MAA, annual reports, ISE & ISS); writing nonclinical reports and tabulated summaries a plus
- Proficient with Microsoft Word, Excel, Project, and PowerPoint
- Working knowledge of GCP, 21 CFR, CTD, ICH guidelines/regulations, and the drug development process is required
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