Regulatory Writer
Regulatory Writer
Posted on :
18-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Description Summary
To write review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide documentation related consultancy to other line functions.Job Description
Major accountabilities:
- To author and review high quality clinical and safety documents: nonregistration Clinical Study Reports (CSR) Development Safety Update Reports (DSUR) Risk Management Plans (RMP).
2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.
3. Core member of Clinical Trial Team (CTT) / participate in Safety Management Team (SMT).
4. Actively participate in planning of data analyses and presentation used in CSRs.
5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
6. May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
7. Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
8. Support the development of RWS through participating in RWS workstreams and other related activities.
9. Contribute to development of processes within RWS. May contribute to crossfunctional initiatives.
10. Fostering crossfunctional communication to optimize feedback and input towards high quality documents.
11. Maintain audit SOP and training compliance.
Key performance indicators:
- Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards Customer / partner/ project feedback and satisfaction Adherence to Novartis policy and guidelines
Minimum Requirements:
Work Experience:
- Minimum 35 years of medical writing experience or 13 years of experience with MBBS/PhD.
- Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies key documents approval processes safety reporting requirements).
- Knowledge of process for and some experience in global registering of (simple submissions).
- Excellent communication skills (written verbal presentations) Very good understanding of biostatistics principles.
- Ability to prioritize and manage multiple demands and projects.
- Ability to define and solve complex problems (Problemsolver)
- Broad knowledge and future oriented perspective
- Proven track record in matrix environment
- Experience in contributing to global crossfunctional projects.
- Global crosscultural perspective and customer orientation
Skills Desired
Clinical Research Clinical Trials DetailOriented Medical Writing Regulatory Compliance SafetyEmployment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
