Regulatory Medical Writer
Full Time, Homebased, however local to PA
The Medical Writer is responsible for the management and preparation of a variety of clinical documents including protocols, clinical study reports, narratives, and investigator brochures for Phase I to IV clinical trials. The Medical Writer is expected to deliver high quality regulatory documents that meet ICH standards, FDA and EMEA (if necessary) guidelines, project timelines, and client specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Writes and/or edits clinical study reports (CSRs), investigator brochures, informed consent forms, patient information, clinical summary documents including Integrated Summaries of Safety and Efficacy, study protocols, and clinical/preclinical sections of INDs, NDAs, etc., in accordance with FDA and ICH guidelines.
- Serves as the primary contact for the customer and the sponsor (if not the same entity) for all project-specific medical writing tasks awarded to company.
- Participates in the development of scientific manuscripts and abstracts describing clinical/preclinical study data, as well as slide and poster presentations.
- In cooperation with the Project Manager attends meetings and teleconferences with the study sponsor, clinical project team and other reviewers to understand and resolve the initial requirements to the document(s), and any further comments and issues.
- Performs quality control review of medical documents.
- Assists in developing strategies for organizing and preparing regulatory documents.
- Converts CSRs, appendices, and other regulatory documents to eCTD submission format.
- BS/BA in life sciences or health-related discipline; PhD, PharmD, or advanced degree in a life science strongly preferred.
- Minimum 2 years medical writing experience at a biopharmaceutical company, CRO, or university medical center compiling clinical study reports (CSRs), protocols, and clinical summaries.
- Demonstrated knowledge of scientific/medical terminology and principles as well as domestic/international regulatory requirements.
- Must possess sound scientific and clinical judgment and be able to convey complex issues effectively through written and oral communication.
- Has significant oncology experience (or other complex therapeutic area experience)
Contact: Nicole Ambrose, email@example.com