Opening in Cactus Medical for Senior Reviewer, Regulatory Writing
Post: Senior Reviewer, Regulatory Writing
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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
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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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