Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Post: Scientific Support- Clinical- Medical Writer
Job Responsibilities:
* Perform Medical Witing activities on the assigned project in a timely and efficient manner
* Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
* To develop Clinical Trial protocols
* To author Clinical Study Reports for Phase 1-4 trials, including full study reports and abbreviated reports
* Ensure high quality, timely communication and project information flow to the Head, Scientific support clinical
* To help in drafting Investigator's Brochure and IB updates once clinical strategy is finalized.
* To assist in template development and management of company specific templates
* To assist in maintaining a standard format for various types of documents that are needed for regulatory submission
* To review SAP and provide inputs
* To review SAR and provide inputs
* To provide research information required for a particular therapeutic area available to all team members as required
* VWite various regulatory reports for Indian as well as global regulatory submissions
* To edit pre-clinical reports required for IND submissions
* To author summaries of pre-clinical reports for inclusion into the Investigators Brochure
* To liaise with pre-clinical development and discovery departments to provide medical writing support for key reports
Education: Master's degree in Life Sciences/Health Related Sciences or equivalent Minimum 2- 3 years of medical writing experience: Experience in writing multiple clinical study reports, and either CTD documents or similar, or study protocols Excellent interpersonal, verbal and written communication skills Demonstrated understanding of the drug development process and a broad knowledge of FDA and DCGI guidelines.
Extensive clinical/scientific writing skills.
Additional Information:
Experience: 2-3 years
Location: Goregaon, Mumbai
Department: Scientific Support-Clinical
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
Education: M.Sc, M.Pharm
End Date: 15th April, 2014
In case you wish to apply to this position, please send us your CV
Applications may be sent to. research.recruitment@piramal.com
The subject line may read ' Application for Medical Writer - MW1M'
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