Contract, Bergen County, NJ (1 year contract / full time hours – up to 3 days / week from home ; 2 days must be on site)
Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. Responsibilities include prepare regulatory documents on behalf of the company in accordance to ICH guidelines, international regulations, company standards and processes, and the company Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, addenda, errata. Investigator brochures, new drug advisory submission documents. Participate in clinical study and project team meetings to provide input regarding deliverables, timelines, and processes needed.
Administer the receipt, collation, and incorporation of review documents.
Route documents for approval. The medical writer must be familiar with ICH guidelines and the AMA Manual of Style, 10th edition. The writer will be asked to format and manage long documents with multiple review cycles and tight deadlines.
- Excellent writer, good organizational and communication skills.
- Strong attention to detail.
- Proficiency using eDMS.
- Strong analytical ability to interpret clinical data.
- 7 years writing exp in pharma industry.
- Bachelor’s degree in life sciences, RN, Master’s degree in life sciences, PharmD or MD preferred.
- Can work remotely but must work 2 days min onsite. Excellent writing skills, compulsive attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data.
7 years writing experience in the pharmaceutical industry. A copyediting test will be required during the interview.
Megan Kilgannon, Recruiter
888-228-7165 x4236 (toll free)