3.0 - 5.0 years

1 - 3 Lacs

bhiwadi, delhi / ncr

Work from Office

Role & responsibilities Preparation of CTD/ACTD & Country specific Dossiers Handling queries obtained from different regulatory agencies and customers across the world. Compilation, preparation and review of Technical Package of APIs. Compliance to audits of regulatory bodies especially USFDA and EU. Generation of documents from, Production, QC and QA of newly developed products Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary document...

Posted 1 month ago

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Narrative writing Tata Consultancy Services

5.0 - 10.0 years

8 - 18 Lacs

noida, bengaluru, mumbai (all areas)

Work from Office

TCS is Hiring - Narrative writing location - Mumbai, Noida, Bengaluru Experience Range - 5 to 10 Interested Candidate can mail on - s.laharika@tcs.com Preferred Educational Qualification for the role - Any life science Postgraduate, BDS, MDS Skills: CSR narrative, common technical document, clinical study report, Narrative writing, investigator brochure, protocol writing Job description: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according ...

Posted 1 month ago

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Medical Writing Specialist Novo Nordisk

10.0 - 14.0 years

0 Lacs

karnataka

On-site

The Clinical Reporting Unit at Novo Nordisk is seeking a skilled and experienced individual to join their team. As a Medical Writer, you will be responsible for performing high-complexity medical writing tasks and acting as a project manager. Your role will involve planning, developing, and overseeing various regulatory documents, including Protocols, Clinical Trial Reports, Investigator Brochures, and Regulatory response documents. Additionally, you will lead discussions, drive project strategy, and ensure clear communication of clinical data. In this position, you will also be expected to contribute to process improvements, knowledge sharing, and mentorship of other medical writers. Mainta...

Posted 1 month ago

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Sr. Medical Writer - Regulatory Writing Gi Group

8.0 - 13.0 years

15 - 27 Lacs

Bengaluru

Work from Office

Job Title: Senior Medical Writer Regulatory Writing Education Requirements: MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech Location: Bangalore (Hybrid as applicable) Experience: 8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5. Role Purpose: This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions. Key Responsibilities: Independently prepare and review regulatory documents such as clinical study reports (CSR...

Posted 3 months ago

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Associate Manager - Clinical Regulatory Writing Indegene

9.0 - 14.0 years

20 - 30 Lacs

hyderabad, bengaluru, mumbai (all areas)

Hybrid

Role & responsibilities We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com If this excites you, then apply below. Associate Manager – Regulatory Writing (Clinical) EXPERIENCE: 10 to 12 years’ experience in writing Clinical & Regulatory documents supp...

Posted Date not available

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