Senior Medical and Regulatory Writer

Job Duties and Responsibilities: 61 Write, edit, format, compile and review assigned documents requested by internal cross-functional teams and/or clients 61 Create, monitor and maintain timelines for medical and regulatory writing projects 61 Prepare clinical and regulatory documents, e.g., clinical study reports, protocols and amendments, investigator brochures, clinical and non-clinical summary documents, etc. 61 Coordinate overall quality review of documents 61 Manage large and complex medical and regulatory writing projects which may include supervision of other medical writers and quality reviewers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards 61 Provide support to other medical and regulatory writers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards 61 Support business development in project bids and new business proposals 61 Mentor and/or supervise Medical and Regulatory Writers and Quality Reviewers as required 61 Train other Medical and Regulatory Writers and Quality Reviewers as required 61 Support Regulatory Strategic Development team efforts on medical and Regulatory Writing projects 61 Participate in client meetings and other project-related meetings and teleconferences as needed 61 Any other activities related to the position as required by direct supervisor 61 May provide oversight to less experienced members of the Medical and Regulatory Writing team Supervisory Responsibilities: No supervisory responsibilities. Job Requirements: 61 Education o A university degree in the field of Life Sciences, Medicine or related field; Graduate/postgraduate degree highly preferred 61 Experience o At least 5 years of relevant Medical and Regulatory writing experience in the Pharmaceutical industry, CRO experience a plus