Indegene Lifesystems Pvt. Ltd. is a leading global provider of scientific and medical services for pharmaceutical, biotechnology, and health care organizations. Through offices and subsidiary companies across the world, we provide the complete spectrum of medical education, scientific communications, sales training, medical intelligence, advocacy, key opinion leader management, and brand solutions to our clients worldwide.
Post: Regulatory Writer
Job Description:
- Interface with clients on a regular basis to meet their expectations for regulatory and safety documents.
- Author safety summary documents and reports such as clinical overviews, clinical summaries, labelling justification documents, RMP REMS, aggregate reports etc. as per client specifications, templates, style guides and other guidance documents.
- Review and assess quality and integrity of data, documents and timelines of delivery. Ensure that documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with client-specific SOPs.
- Provide direction and guidance to medical writers in India on a range safety documents.
- Provide guidance and support to all team members on a project with regard to format, style, content, and compliance.
- Guide and mentor team members to ensure consistency and completeness of the project
- Provide peer review for colleagues in support of all documents.
Candidate Profile:
* Minimum 5 to 10 years of experience in working with or in pharmaceutical companies in Regulatory writing and Safety writing.
* Preferred area of TA expertise: Oncology
* Ability to synthesize data and present it in a written format.
* Understanding of document creation process and able to lead/own a study level document.
* Collective experience writing a range of safety documents for various therapy areas:
- Investigator’s Brochure
- Labeling Justification Documents
- Clinical Overviews and Clinical Summaries
- Safety Narratives
- Aggregate Reports
- Risk Minimization Plan and REMS
- ADR Frequency Assessment
* Strong written and verbal communication/presentation skills; with flair for writing.
Additional Information:
Education: M.Phil, M.S./ M.D., M.Sc., MBBS, Ph.D, Pharm.D
Location: New Jersey
Experience: 5-10 years
Functional Area: Scientific Content
Last Date: 31th Dec, 2013
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