Cactus Medical offers medical writing services to multinational pharma, clinical research organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team of medical writers, researchers and healthcare professionals who want to explore the field of medical writing, be part of a world-class delivery team, and work in an exciting, fast-paced global environment.
Post: Senior Reviewer, Regulatory Writing
Job Description
* Ensure timely production of high quality regulatory documents (clinical study reports, investigator brochures, protocols (phase 1-4, periodic safety update reports, etc.) across therapeutic areas
* Review documents and provide meaningful feedback to medical writers
* Provide formal or informal coaching to regulatory writers by sharing technical information, giving guidance (e.g., best practices), answering questions, and directing them to the appropriate resources
* Provide quality-related coaching or mentoring to team members, as appropriate
* Develop and maintain necessary templates, formats and style guides to ensure that documents generated meet client requirements
Candidate Profile:
PhD (preferably in the pharmaceutical sciences)/MBBS/MD with knowledge of clinical research
* At least 5-8 years of regulatory writing experience (clinical study reports, investigator brochures, protocols (phase 1-4), periodic safety update reports, etc.)
* Advanced knowledge of clinical research processes and drug development, as well as ICH, GCP, and other such industry guidelines
* Experience across document types and therapeutic areas/diseases/drug classes
* Ability to understand and interpret complex clinical trial data
* Clear, concise scientific style of writing with a high level of attention to detail
* Prior experience writing entire regulatory documents
* Good written and oral English language skills
* Ability to work under tight timelines and manage multiple tasks
Compensation: Excellent compensation package will be offered to deserving candidates
Subsidized accomodation and relocation support will be provided to outstation candidates.
Apply: E-mail your updated CV along with a cover letter to jobs@cactusglobal.com
Additional Information:
Experience: 5-10 years
Location: Mumbai
Education: Ph.D, M.Pharm, MD, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
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