Regulatory Medical Writer

Gratitude India Manpower Consultants Pvt. Ltd.

2 - 7 years

3 - 6 Lacs

mumbai suburban

Posted:Just now| Platform:

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Skills Required

clinical operations fda regulatory regulations clinical trials ich-gcp guidelines drug safety pharmacovigilance ich psur clinical research case processing meddra mdr

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled Regulatory Medical Writer with 1 to 6 years of experience to join our team in Mumbai. The ideal candidate will have a strong background in regulatory affairs and medical writing, with excellent communication and analytical skills.

Roles and Responsibility

Develop high-quality regulatory documents, including clinical study reports, marketing authorizations, and other related materials.
Collaborate with cross-functional teams, including regulatory affairs, product development, and clinical operations.
Conduct thorough reviews of regulatory documents to ensure accuracy, completeness, and compliance with regulatory requirements.
Stay up-to-date with changing regulatory requirements and guidelines, ensuring timely updates to internal stakeholders.
Provide training and support to junior writers on regulatory affairs and medical writing best practices.
Participate in the development of new regulatory strategies and initiatives, leveraging expertise in regulatory affairs and medical writing.

Job Requirements

Strong understanding of regulatory affairs, including FDA, EMA, and other global regulatory requirements.
Excellent writing, editing, and communication skills, with the ability to convey complex information clearly and concisely.
Ability to work independently and collaboratively as part of a team, demonstrating flexibility and adaptability.
Strong analytical and problem-solving skills, with attention to detail and the ability to meet deadlines.
Experience with regulatory document management systems, such as TrackWise or similar tools.
Familiarity with Good Clinical Practice (GCP) principles and regulations governing clinical trials.

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