Cactus Communications—a company dedicated to the pursuit of good English. We provide editing, educational, transcription, and training services to individual and institutional clients worldwide. All our businesses are linked together by one common factor—great written English. Since our establishment in April 2002, we have carved a niche for ourselves as a company providing language solutions of the highest quality.
Post: Senior Regulatory Writers
Job Description
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, experienced medical writers who have regulatory writing experience and aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.
As a regulatory writer in the Cactus Medical team, you will:
* 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
* Work on documents across therapeutic areas
* Work with senior medical writers to prepare documents that meet client expectations
* 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
E-mail your updated CV along with a cover letter to jobs@cactusglobal.com
Additional Information:
Experience: 5-8 years
Location: Mumbai
Education: MBBS, M.Pharm, MD, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
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