Head, Regulatory Writing - Cactus Communications Pvt. Ltd.

By: Pharma Jobs | Views: 2147 | Date: 15-Jul-2011

Job detail for the post of Head, Regulatory Writing in Cactus Communications Pvt. Ltd. Mumbai, 3 to 8 years of experience. Apply for the job Now ! Search Jobs in India by Functional Area, Industry and Location. Search Jobs in India - Delhi, Mumbai, Bangalore, Kolkata. Find career openings in top companies. Post your resume and find your dream job Now !.

Experience:

3 - 8 Years

Location:

Mumbai

Education:

UG - MBBS - Medicine PG - M.S/M.D

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Bio/Pharma Informatics-Associate/Scientist

Functional Area:

Healthcare, Medical, R&D

Posted Date:

15 Jul

Desired Candidate Profile

Qualification: PhD (preferably in the pharmaceutical sciences)/MBBS/MD with knowledge of clinical research



Experience:



  • 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

 

 

 

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.



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
  • 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

 

Keywords: PhD, MS, MD, Pharmaceutical medicine, regulatory writer, regulatory writing, clinical study reports, investigator brochures, team lead, manager

Company Profile

Cactus Communications is a pioneering language services company serving more than 25,000 clients across 73 countries. In line with its mission—growth through effective communication, Cactus offers specialist academic editing, medical communications, publication support, transcription, and training services to individuals and corporations across sectors such as academia, publishing, and pharmaceuticals.

Combining the rich and diverse experiences of a multi-national, multi-functional team; the peerless capabilities of over 600 language and business professionals; and ingenious technological innovation, Cactus helps researchers, journals, universities, and corporations achieve their publication goals. The Cactus culture is an eclectic yet inclusive one, wherein people from different countries, cultures, and backgrounds come together as part of a global team that pursues excellence and prizes integrity as it builds a dynamic, client-focused organization that makes a difference.

Offices
Philadelphia, USA | Tokyo, Japan | Mumbai, India | Seoul, South Korea | Shanghai, China |Taipei, Taiwan ROC

Awards and recognitions
Ranked 13th in the ‘Best Companies to Work For 2011’ survey by the Great Place to Work for Institute
Red Herring Global 100 Award 2010, for innovation in business
Featured among the Top 15 Exciting Emerging Companies 2008, in a NASSCOM survey
Contact Details
Company Name:

Cactus Communications Pvt. Ltd.

Website:

http://www.cactusglobal.com

Executive Name:

Fatima Khan

Address:

Not Mentioned

Telephone:

Not Mentioned

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