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: Deputy Manager/Manager - Clinical Medical Writing
Job Description:
Perform Medical Writing 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.
Ensure compliance of operations with governing regulatory requirements.
Create, maintain and assume accountability for a culture of high customer service.
Write various regulatory reports for Indian as well as global regulatory submissions.
Write Investigator brochures and sections of Clinical Study Protocols.
Write Clinical Study Reports for Phase 1-4 trials, including full study reports and abbreviated reports.
Perform Quality control of written documents and ensure they meet the required standards.
Development of SOPs and processes for Medical Writing in compliance to regulatory requirements.
Review of Informed consent forms, Case Report Forms, Statistical Analysis Plan, TLFs for CSR and other regulatory documents.
Desired Profile:
M.Pharm / Medical Science Graduate
At least 4-6 years’ experience in the R&D pharmaceutical industry/CRO, with at least 2 years of it in medical writing, preferably pre-clinical, clinical and regulatory medical writing.
Skills:
Good understanding of regulatory requirements and ICH-GCP guidelines.
Highly motivated team player with well-developed oral and written English communication skills.
Strong scientific writing, data compilation and analytical skills.
Ability to handle multiple assignments and meet deadlines.
Additional Information:
Experience: 4-6 Years
Location: Goregaon, Mumbai
Education: M.Pharm, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR, Medical Writing
Job Code: DM/MGR-Medical Writing-001
End Date: 15th July, 2012
Interested candidates may send us CVs by 15th July 2012.
Applications may be sent to research.recruitment@piramal.com.
The subject line may read 'Application for DM/MGR-MW-001'.
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