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: Associate Medical Writer
Job Description:
Job Summary: As an Associate Medical Writer you would work on Clinical Study Documents, mainly Narrative Writing.
Key responsibilities:
Under divisional supervision as needed, the Associate Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with regulatory submissions. The Associate Medical Writer 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 Associate Medical Writer may serve as primary technical contact with the client under appropriate divisional supervision.
The position is focused but may not be limited to the handling of documents and communication associated with the submission to Independent Ethic Committee(s) and the local Regulatory Authorities in India or other global regulatory bodies.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
• Write clinical documents associated with submissions to regulatory authorities including but not limited to Study protocols, Informed consent documents, Clinical study reports, Submission forms for regulatory bodies.
• Prepare clinical study reports to regulatory standard for e-submission.
• Assist with preparation and compilation of appendices to clinical study reports.
• Translate documents to German, as required.
• May supervise collection of materials by Medical Writing Assistant for assembly of client deliverables and for filing appropriately in Central Files, project files and Medical Writing archives.
• Ensure document content and style adheres to appropriate regulatory guidelines, and complies with company or client SOPs and style guidelines, Teamwork within Medical Writing and the Unit
• Attend internal technical team meetings
• May participate in divisional or interdivisional process improvement and training initiatives
• Serve as the Medical Writing representative on assigned project teams.
Candidate Profile
The ideal candidate for this role would be a PhD, MBBS (or equivalent Indian Medicine degree), BDS/MDS, MSc with excellent English Language/Communication skills (the latter is mandatory). Experience in corporate regulatory medical writing is not mandatory however, experience in any type of writing (literature, own research, magazine or newspaper writing) would be an advantage.
Additional Information:
Location: Andhra Pradesh - Hyderabad
Functional Area: Medical Writer
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 28th Feb., 2014
Req ID: pare-10026849
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