Job Description

Medical Writer

The Medical Writer is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, health authority briefing books and clinical summary documents for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.

Responsibilities and Duties:

• 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 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.

Educational Requirements:

• Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.

Experience:

• 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.
• 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).

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