Regulatory Medical Writer, Telangana
Regulatory Medical Writer, Telangana
Sandoz
Job description
Interested in a career in medical affairs and regulatory medical writing? Check out the Medical Manager role at Sandoz in Telangana, India. This role involves preparing scientific and clinical documents for the renewal of product marketing authorizations, and contributing to responses to health authority.
Company Description
Sandoz is a worldwide pharmaceutical firm focused on generic and biosimilar medications. It works through pharmaceutical discovery, production and collaborations to boost access to affordable, high-quality therapies. The company works in many countries and is working to improve access to important medicines, while supporting sustainable healthcare and innovation.
Job Summary
This is a full time role, located in Telangana, India to prepare medical and clinical documentation required to retain pharmaceutical product authorizations. The Regulatory Medical Writer will facilitate product lifecycle management by drafting expert statements, updating clinical data and generating evidence-based answers to inquiries or deficiency letters from health authorities. They will also support global product labelling harmonization and indication expansion operations, and ensures that submitted documents are scientific and quality compliant.
Key Responsibilities
Prepare documentation required for the timely renewal of marketing authorizations for products.
Draft clinical and non-clinical expert opinions to assist regulatory filings.
Create product maintenance and lifecycle management addenda to clinical overviews.
Respond to deficiency letters and queries from health authorities with scientifically-sound and literature-supported responses.
Support Global Labelling team with harmonization of product information and labels across markets.
Participate in regulatory documentation for product indication expansion operations.
Medical and clinical documentation must be consistent with the latest scientific evidence and quality requirements.
Read paperwork well to cut down on follow-up questions from internal stakeholders and regulators.
Support regulatory efforts and meet submission deadlines in collaboration with cross-functional teams.
Educational Qualification
Bachelor degree in a medical or allied health care field is essential.
Experience in medical writing/regulatory medical writing (2-3 years).
Skills Required
Medical writing and regulatory writing.
Preparation of expert reports, clinical and non-clinical.
Review of scientific material and production of evidence-based documents.
Understanding of regulatory standards for marketing authorizations.
Experience in product lifecycle management, medication development.
Regulatory labelling changes and product label harmonization.
Able to provide straightforward and scientifically sound answers to questions from health authorities.
Critical thinking and prioritization of time-sensitive tasks.
Strong attention to detail.
Excellent written communication skills.
Experience working in a matrix environment with cross functional teams.
Learning agility & flexibility to changing project requirements.
Excellent working understanding of Microsoft Office applications.
Salary Structure
The average yearly compensation of a Regulatory Medical Writer in India is Rs.6 Lakhs to Rs.8 Lakhs per year.
Career Development
This role can enable individuals to develop competence in regulatory medical writing, clinical documentation, product lifecycle management and health authority communication. With more experience, career options include senior scientific medical writing, regulatory affairs management and leadership of medical documentation.
How to Apply
Go to our official job portal and look for Regulatory Medical Writer, Telangana job.
Click on the listing to get the full description.
Provide your data and attach your latest resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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