RN Specialist at Advocate Health ensuring accurate clinical documentation and coding compliance. Collaborating with healthcare teams to improve patient record quality and completeness.
About the role
- Senior Medical Writer at GSK creating clinical documents and collaborating with stakeholders. Working independently on assignments while ensuring compliance and quality standards in clinical writing.
Responsibilities
- Completes assignments independently or for more 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
- Actively participates in all planning, coordination and review meetings
- Ability to work on 2-3 assignments simultaneously
- Proactively raises and discusses concerns/issues in an open and timely manner
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
- 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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