What are the responsibilities and job description for the REMOTE* Medical Writer position at Piper Companies?
*MUST HAVE PRIOR LEAD AUTHOR EXPERIENCE*
Piper Companies is currently searching for a Medical Writer to work remotely for a full service, biopharmaceutical CRO.
Responsibilities of the Medical Writer include:
- Compose IND modules, NDA modules, and other regulated regulatory documents
- Write clinical study reports, protocols, and protocol amendments
- Oversee quality control reviews of those documents and maintain audit trails of changes
- Serve as a point of contact for the sponsor and other subject matter experts
Qualifications of the Medical Writer include:
- Knowledge of regulations and medical terminology
- 3 years of prior medical writing experience in the clinical research or pharmaceutical industry
- Ph.D., PharmD, MD, or Master’s Degree in Scientific Field
Benefits for the Medical Writer include:
- Salary of $125-$135k, commensurate with experience
- Full benefits: Medical, Dental, Vision
- 401k options
Keywords:
CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, quality assurance, qa, capa, investigations, audit, certified quality assurance auditor, CQA, medical writing, Investigational New Drug applications, IND, FDA, IB, annual reports, preclinical reports, clinical study reports, safety reports, investigator brochure, literature search, data analysis, medical terminology
