Regulatory Medical Writer

Gratitude India Manpower Consultants Pvt. Ltd.

2 - 7 years

3 - 6 Lacs

navi mumbai

Posted:-1 days ago| Platform:

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Skills Required

quality assurance regulatory regulations pharmacovigilance ich quality management quality control clinical research qms drug safety clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled Regulatory Medical Writer with 6 to 10 years of experience to join our team at Gratitude India Manpower Consultants Pvt. Ltd., located in the IT Service & Consulting industry.

Roles and Responsibility

Develop high-quality regulatory documents, including clinical trial applications and marketing authorizations.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Conduct thorough research and analysis of medical literature to support document development.
Prepare and review draft documents for accuracy, completeness, and adherence to regulatory standards.
Coordinate with internal stakeholders to gather necessary information and input for document preparation.
Ensure timely submission of documents to meet project deadlines.

Job Requirements

Strong understanding of regulatory requirements and guidelines governing pharmaceutical products.
Excellent writing, editing, and communication skills are required to produce clear and concise documents.
Ability to work independently and collaboratively as part of a team to achieve project goals.
Proficiency in using document management systems and software for tracking and managing documents.
Strong analytical and problem-solving skills are needed to resolve issues related to document development.
Familiarity with ICH guidelines and other relevant regulations governing pharmaceuticals is essential.

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