1.Independently write and QC/review patient narratives.
2.Independently lead narrative projects.
3.May coach other writers.
4.Follow and track clinical trial milestones and resource requirements for assigned projects.
5.Act independently as document consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.
6.Act as liaison between clinical trial teams and publishing to ensure timely delivery of final documents for publishing.
7.Support process improvement initiatives
8.Maintain audit, SOP and training compliance.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Employment Type: Permanent Job, Full Time
Project Management Process Improvement Initiatives Clinical Development Life Sciences Management Skills
Desired Candidate Profile:
Minimum university life science degree. Advanced degree or equivalent education/ degree in life sciences/ healthcare is desirable. Excellent written and verbal English
1.At least 2 years of relevant experience. Advanced degree: 0-2 years of experience
2.Good document creation and editing skills.
3.Basic knowledge of clinical documentation.
4. Good project management skills.
5.Basic knowledge of clinical development.
UG: B.Sc – Any Specialization
PG:Any Postgraduate – Any Specialization
Doctorate:Doctorate Not Required
Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
Contact Company:Novartis Healthcare Pvt Ltd