Senior Medical Writer - Remote based
Proclinical is currently recruiting for a Senior Medical Writer for a research program located in Princeton, NJ. Successful candidate must be a motivated individual with science, research and/or clinical background who would like the opportunity to be involved in the development of many new products being evaluated for the treatment of cancer.
- Prepare documents for regulatory submissions, including (but not limited to) Initial Investigational New Drug (IND) applications and amendments, clinical study reports, annual reports, clinical study protocols/amendments, informed consents, investigator brochures, briefing/meeting packages.
- Handle regulatory submission requirements and processes.
- Assist with responses to questions from regulatory agencies.
- Provide writing/editing services and QC to other in-house units.
- Serve as a resource for new medical writers.
- Lead cross functional project teams and act as a project leader with manager oversight.
Skills and Requirements:
- Minimum of a BA/BS in Science. Advanced degree in a health-related science is desirable
- 5+ years of experience in medical writing or regulatory affairs
- Knowledge of ICH guidelines, drug regulation guidances, drug development processes
- Oncology writing experience within Pharma, Biotech and/or CRO environment
- Lead author of clinical and regulatory documents
- Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook)
- Familiarity with eCTD format
- Excellent written and verbal skills
- Ability to collaborate across departments and relate effectively to people at all levels of the company
- Highly organized, self-motivated, and extremely detail-oriented
- Proven ability to work independently, meet deadlines and be results-oriented
- Ability to manage critical issues on multiple projects simultaneously
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4835 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.
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