Medical Writing Specialist developing regulatory documentation for medical communications. Collaborating closely with cross - functional teams and ensuring compliance with EU and FDA standards.
About the role
- Senior Medical Writer preparing clinical documents and ensuring data integrity at GSK. Collaborating with various roles to maintain high standards in regulatory submissions and contributing to patient impact initiatives.
Responsibilities
- Completes assignments independently or for complex documents, under guidance of a mentor
- Authors a range of clinical documents, including regulatory documents following defined templates
- Ensures high integrity of data interpretation, following negotiation with document team
- Ensures the consistency and quality level of all documents that are issued
- Actively participates in all planning, coordination and review meetings
- Proactively raises and discusses concerns/issues in an open and timely manner
- Works directly with a diversity of roles at different levels within GSK
- Establishes network of communication and continuously builds collaboration with all groups involved in delivery of writing assignments
Requirements
- Up to 5 years clinical regulatory writing experience in the pharmaceutical industry
- Possesses a good understanding of basic drug development
- Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
- Demonstrates understanding of how to interpret, describe and document clinical data
- Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)
- Possesses necessary computer skills and general computer literacy
- Excellent English language skills (verbal and written)
Benefits
- Private healthcare
- Additional paid days off
- Life insurance
- Private pension plan
- Fully paid parental leave & care of family member leave
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