Contract Regulatory Medical Writer/pharma-home based
- Princeton, New Jersey
- Pharma & Biotech
A pharmaceutical client of mine based in NY is seeking to hire a Senior/Principal level Regulatory Medical Writers to join them ASAP. This opening can be worked remotely/from home; however, you must be able to come to NY for required meetings.
Position: Senior Medical Writers/Regulatory Medical Writer/Contract Medical Writer
Contract length: ASAp- End of 2019, potential to renew
Location: work from home based/remote
Hours: 40 hours/week- EST hours
- Writing, editing, and reviewing of clinical documents including but not exclusive to
- Investigator Brochures (IBs), protocol synopses, protocols (Phase 1-3), clinical study reports (CSRs), narratives, integrated safety and efficacy summary documents (ISS/ISEs), clinical portions of Investigational New Drugs (INDs), New Drug Applications (NDAs) and ANDAs, as well as the review and revision of SOPs.
- Ensures document quality, compliance with SOPs and reviews clinical documents for consistency with company style guide, FDA, CTD, and other regulatory guidelines.
- Collaborates with document project team members to establish timelines and priorities
- Conducts document Kick-Off-Meetings (KOMs) and facilitates cross-functional document review meetings (e.g., Protocol Review Committee (PRC), CSR review meetings, etc.)
- Participates in process improvements and enhancement of templates for the medical writing function.
- Contributes to establishing vendor requirements for medical writing needs. Serves in an oversight capacity for outsourced medical writing deliverables.
· PhD degree preferred in a scientifically-related area. Master's degree required. If no Master's degree, equivalent work experience will be considered.
· Knowledge of FDA Pharmaceutical Guidelines and Common Technical Document (CTD) format
· Experience in assembling scientifically complex data or information to develop documents such as a clinical trial final study report, clinical trial protocol, or other specific document for regulatory submission.
· Excellent oral and written communication skills along with ability to listen effectively to others
· Skilled in problem identification and solving, including ability to negotiate and influence
· Previous experience in the participation and preparation of clinical documents for regulatory submission (e.g. clinical protocols, INDs) is a must
· Proficient in the MS Office Suite with expertise in MS Word and prior experience using and Adobe Acrobat and SharePoint. Experience with MS Project is preferred.
Sthree US is acting as an Employment Business in relation to this vacancy.