Position - Manager -Medical Writer
Department - Medical Affairs

Job Responsibilities:

- Designing of preclinical studies as per the regulatory requirements to support the clinical bridging.
- Preparation and review of preclinical study synopsis, study protocol and reports.
- Preparation and Review of clinical development strategies.
- Preparation and Review of clinical study synopsis.
- Preparation and review of regulatory submission documents like Scientific advice, Pre­ IND package, controlled correspondence.
- Preparation and review of Initial pediatric study plans (iPSP).
- Identification of unmet needs through active stakeholder interactions and actively contributes in the new product ideation and development of differentiated products.
- Preparation of slides on medical rationale for differentiated products.
- Preparation and Review of non-clinical overviews, Clinical overviews, Investigator's Brochure (IB).
- Preparation and review of clinical documents for Marketing Authorization Application
- (MAA).
- Preparation and review of presentation, executive summary for SEC meetings (CDSCO).
- Preparation and review of manuscripts for paper publication in peer reviewed journals.
- Providing literature support for regulatory queries and regulatory literature search for various drug molecules.




- Supporting clinical research aspects of products in development and supporting other miscellaneous activities, where medical reviewer intervention is needed.

. Skillset Required: Designing of preclinical studies, Regulatory requirements, Preparation of preclinical study synopsis, Preparation of study protocol, Preparation of study reports, Preparation and review of clinical development strategies, Preparation and review of clinical study synopsis, Preparation and review of regulatory submission documents, Scientific advice, Pre-IND package, Controlled correspondence, Preparation and review of Initial pediatric study plans (iPSP), Stakeholder interaction, Current product ideation, Product development, Preparation of slides on medical rationale, Preparation and review of non-clinical overviews, Preparation and review of clinical overviews, Preparation and review of Investigator's Brochure (IB), Preparation and review of clinical documents for Marketing Authorization Application (MAA), Preparation and review of presentations, Preparation and review of executive summaries for SEC meetings (CDSCO), Preparation and review of manuscripts for peer reviewed journals, Literature support for regulatory queries, Regulatory literature search, Support of clinical research, Medical reviewer intervention

📌 Manager - Medical Writer (India)
🏢 Talental Consultings
📍 India