PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Medical Writer II
Job Description
Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as primary technical contact with client under appropriate departmental supervision.
Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, model informed consents, interim and final clinical study reports and safety updates. Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision. Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
Qualifications:
Medical writing experience: experience in writing multiple clinical study reports or other regulatory documents.
Additional Information:
Location: Karnataka - Bangalore
Functional Area: Medical Writing
Requisition: pare-10058388
Industry Type: Pharma/ Biotech/Clinical Research
End Date:16th August, 2017
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