Remote Job
Managerof Medical Writing -Remote
Aequor- 5000 - 6000 USD per Month
- Full Time
- Posted : 11 months ago
TITLE: Manager of Medical Writing
- Responsible for the development of high quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.
- Collaborates with Global Development Teams and Clinical Development to ensure alignment with program objectives.
- Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors.
- Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
- Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
- Owns and updates assigned Medical Writing SOPs, as necessary.
- Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
- Minimum of 5 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
- Previous experience in Medical Writing in clinical drug development, preferably some experience in Oncology.
- Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
- Knowledge of template development, document management systems and requirements.
- Strong working knowledge of Medical Writing requirements and document components.
- Good interpersonal skills that involves working well in a team environment and the ability to lead others.
- Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized ).
Skills
- Medical Writing
- Clinical Protocols
- Document Management Systems (DMS)
- Interpersonal Communication
- Writing
