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Senior Scientific Writer
GSKSenior 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.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Private healthcare
- Additional paid days off
- Life insurance
- Private pension plan
- Fully paid parental leave & care of family member leave
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical regulatory writingdata interpretationscientific methodologystatistical principlesclinical research documentationdrug development knowledgecomputer literacy
Soft Skills
independent workcommunicationcollaborationproblem-solvingparticipation in meetings