Regulatory Medical Writer
ProClinical, in support of our client, are currently seeking a collaborative individual to fill the role of Regulatory Medical Writer, based in Princeton, NJ. The successful individual will be involved in the development of many new products being evaluated for the treatment of cancer.
- Prepare 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 Qualifications
- BA/BS in relevant field - advanced degree in health-related science preferred.
- 3-5 years of experience in medical writing or regulatory affairs. Oncology writing experience within Pharma, Biotech and/or CRO preferred.
- Knowledge of ICH guidelines, drug regulation guidance, drug development processes, etc.
- Lead author of clinical and regulatory documents
- Familiarity with eCTD format.
- Proven ability to work independently, meet deadlines and be results-oriented.
- Excellent written, verbal, and interpersonal communication skills.
- Strong computer skills, especially Microsoft Office Suite.
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) 336-842-8682 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.