Sr Manager - Regulatory Writing - Clinical Trials

Discipline - Healthcare and Life Sciences

Subsector - Clinical Trials

Location - Mumbai

About our Client - Our client is a leading scientific communications company with global operations. They provide fully integrated cost - efficient communication solutions and high quality clinical documentation for major pharmaceutical companies. Their services include Regulatory writing, QC auditing, Scientific editing across all therapeutic areas. They are looking for a Sr Manager - Regulatory Writing to be based in Mumbai.

Job Description - Reporting to the Head - Regulatory Writing, you will be responsible for Ensuring timely production of high quality regulatory documents (clinical study reports, investigator brochures, protocols (phase 1-4, periodic safety update reports, etc.) for the clients based out of Asia, Europe and US.

- Coordinating with the business development team when required to provide technical inputs for RFIs/RFPs/Proposals.

- Developing and maintaining necessary templates, formats and style guides.

- Reviewing documents and providing meaningful feedback to medical writers.

- Managing Key accounts and projects.

The Successful Candidate - You are a MBBS along with a PHD in pharma with 5-8 years experience in regulatory writing. You have excellent knowledge in clinical research and drug development process as well as ICH, GCP and other such industry guidelines. You have the ability to understand and interpret complex clinical trial data. You have clear and concise scientific style of writing with high attention to detail. You have good communication skills and have the ability to multi task.

What's on Offer - Be a part of a start up team of regulatory writers for existing clients as well as new accounts.

- Access to a global network of professionals.

- Attractive Compensation

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