inVentiv International Pharma Services Pvt. Ltd
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You will work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
Job Title: Documentation/Medical Writing
Job Description:
PRIMARY FUNCTION:
The Senior Medical Writer will write, edit, and coordinate content for clinical/regulatory documents while serving as primary technical contact with the internal team and the client.
MAJOR RESPONSIBILITIES:
- Experience in writing, review and project management of Clinical Study Reports across the phases and therapeutic areas
- Review of Statistical analysis plan, Informed consent forms
- Protocols and amendments, Investigators brochure and its updates
- Develop a variety of documents related to regulatory, submissions, abstracts, posters, publications, presentations, medical information letters, records, press releases, brochures, and etc.
- Act as lead for assigned writing projects.
- Manage medical writing projects according to internal or external SOPs and client standards, on-time, on budget and of high quality.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution, including both copyediting and content review.
- Perform peer and quality control review of medical writing documents.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures.
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department
