Medical Writer- I Vacancy in PARAXEL "D3"

Role: Medical Writer- I @ Banglore

Job Summary : As a Medical Writer Iyou 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 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 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.

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.

 Job Qualifications 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: 1 to 3 years corporate regulatory medical writing is ideal for this role. Prior/Academic experience of literature, own research, magazine or newspaper writing would be an advantage. 

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