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Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Medical Writer 3

Job Description:

Job Title: Medical Writer 3

Job Type: Contract

Job Location: Bengaluru, India

Work Schedule: On-site

Rate: 22 lakhs,Based on experience

Joining company means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

This contract-to-hire Medical Writer position reports to Sr. Manager, Medical Sciences and requires a strong candidate with significant experience in medical writing of Clinical Evaluation Reports per EU MDR, in support of submission for CE Mark application as well as CER updates to maintain EU product conformance. Potential for future additional responsibility include authoring other clinical and regulatory documents as well as abstracts and manuscripts for publication. The position will work with the in-house team and support the writing and review of these documents.

Roles and Responsibilities:

• This position has responsibility and authority for the following:
• Authoring Clinical docume

About Alkem:

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.

Roles and Responsibilities

1. Prepare, maintain, and manage risk management plan (RMP) schedules, timelines, and trackers to ensure timely authoring, review, approval, and submission of RMP.
2. Ensure that RMPs accurately reflect the current safety profile of products and are aligned with available clinical, non-clinical, and post-marketing safety data.
3. Ensure all RMPs are compliant with applicable global and regional regulatory requirements, including EU GVP and relevant health authority guidance.
4. Draft, coordinate, and support responses to regulatory authority queries and requests for clarification related to RMP content.
5. Maintain consistency and alignment between RMPs and related safety and regulatory documents, including PSUR/PBRER, SmPC, Package Leaflet and Safety Specifications where applicable.
6. Support the evaluation, justification, and documentation of additional risk minimization measures

Job Title: Medical Writer – Fixed Term Contract (12 months, Full Time) - Orthopaedic Devices

Locations: India

Department: Scientific Operations

About the Role:

We are seeking a Medical Writer to join a dynamic scientific operations team supporting medical device projects. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension. The Medical Writer will create, update, and manage a range of regulatory and clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within their assigned therapeutic area.

Key Responsibilities:

- Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines (MUST HAVE)

- Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis

- Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices

- Compare device safety and performance against the state of the art and investigate unexpected outcomes

- Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents

- Fol