Regulatory Medical Writer

Gratitude India Manpower Consultants Pvt. Ltd.

2 - 7 years

3 - 6 Lacs

mumbai

Posted:1 hour ago| Platform:

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Skills Required

drug safety pharmacovigilance ich regulations regulatory guidelines ich-gcp guidelines ctd clinical research case processing quality assurance regulatory affairs meddra clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled Regulatory Medical Writer with 3 to 8 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, marketing authorizations, and other related submissions.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company standards.
Conduct thorough research and analysis of regulatory guidelines, laws, and regulations to inform document content.
Create clear, concise, and well-structured documents that meet regulatory requirements.
Review and edit documents for accuracy, completeness, and adherence to regulatory standards.
Stay up-to-date with changing regulatory requirements and update documents accordingly.

Job Requirements

Minimum 3 years of experience in regulatory medical writing or a related field.
Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.
Excellent writing, editing, and communication skills.
Ability to work independently and as part of a team.
Strong analytical and problem-solving skills.
Familiarity with regulatory software and systems is an asset.

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