Principal Regulatory Writer- Clinical Focus
Posted on :
11-06-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1138912
- Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
- Lead a project team, actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
- Serve as liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval/agreement from regulatory authorities for all document types that Synchrogenix writes
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor and proactive consultant to collaborate and anticipate the needs of the client based on the relationship and knowledge while looking for new business opportunities
- Take ownership of entire deliverable that include multiple writers
- Manage budget for all types of projects, liaise with finance and mentor others in fiscal responsibility and outcomes at the project level
Employment Type
Remote
Company Industry
Pharma / Biotech / Clinical Research
Department / Functional Area
Journalism / Content Writing / Editing / Correspondent
Key Skills
- Writing
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