Senior Medical Writer, Safety Support Services

About the role

The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content supporting the company's development pipeline and enables data sharing for its customers. The Senior Medical Writer works with a project lead to develop, author, edit and lead the review of accurate, clear and compliant clinical, regulatory and public-facing documents across multiple programs and therapeutic areas.

Key responsibilities

• Prepare clinical regulatory documents (protocols, clinical study reports, participant narratives, investigator's brochures) and public-facing documents (informed consent forms, trial registration and results postings, plain language summaries) according to company and regulatory requirements.
• Collaborate on document-specific cross-functional teams and act as a scientific contributor, keeping project leads and management informed and escalating issues affecting timelines, quality or compliance.
• Apply medical writing best practices such as lean writing and health literacy, and use medical writing tools and platforms.
• Improve medical writing processes and standards, and may mentor new team members or manage direct reports, including workload, professional development and performance.

Required profile

• Bachelor's degree, preferably in a health, scientific or related discipline (life sciences, pharmacy, medicine, public health).
• 3 years of relevant medical writing or industry experience.
• Experience managing multiple writing projects under tight deadlines and leading teams of medical writers and cross-functional members.
• Ability to interpret clinical data clearly and in line with regulatory requirements with minimal supervision, and experience resolving conflicts and negotiating in cross-functional teams.

Required skills

• Strong oral and written communication and presentation skills.
• Technical expertise in common office applications (e.g., Microsoft Office) and shared document systems (e.g., SharePoint).
• Knowledge of clinical development, regulations, disease areas and company products.