Regulatory Writer

393319BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer, you will develop documents which cover all Novartis therapeutic areas and therapies,...

We are seeking a seasoned regulatory writer to join our team.About the Role:This is an exciting opportunity for a highly skilled regulatory writer to develop and manage high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications.The successful candidate will provide authoritative guidance on...

Summary To write review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications To provide authoritative documentation-related consultancy to other line functions To coach mentor and train less experienced writers Major accountabilities To author ...

**Summary**: **About the Role**: **Major accountabilities**: - To author and review high quality clinical and safety documents: non-registration 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...

Regulatory Document WriterWe are seeking a skilled Regulatory Document Writer to join our team. In this role, you will be responsible for writing and reviewing various safety reports for global regulatory submissions.The ideal candidate will have excellent communication skills, attention to detail, and experience in writing safety reports and regulatory...

Senior Safety Writer Job Description">As a Senior Safety Writer, you will play a crucial role in creating and reviewing safety reports for global regulatory submissions. This includes Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.Develop and edit various safety reports to ensure compliance with regulatory...

Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution.  Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports,...

Mumbai Drive and lead end to end solutions in the areas of Medical writing across the sectors - Pharma, consumer and Medical Devices Define and guide development of solutions and functional frameworks in Medical writing Ensure compliance from regulatory perspective Mentor and train teams in the area of Medical writing Expert review of documents ensuring...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

Company DescriptionThe CorpTech Legal Shield works with startups, scaleups, venture capital-backed companies, and technology ventures to navigate the complex intersection of law, innovation, and emerging technologies. Our expertise includes data privacy, cybersecurity, regulatory compliance, IT and software law, AI governance, and intellectual property...