Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Regulatory Writer, Submission Support,& Document Specialist
Responsibilities
Serves as PEH R&D Preclinical Development regulatory submissions writer, submission support, and document specialist This person will prepare and contribute expert nonclinical safety sections to regulatory dossiers and will oversee the integration of all nonclinical contributions (pharmacology/ADME/toxicology) to provide a critical, comprehensive nonclinical assessment of the pharmacologic, pharmacokinetic, and toxicologic attributes.
The individual will also oversee all timelines and reviews associated with the nonclinical summary documents and are responsible for quality review of content for accuracy, correctness, and consistency, and submission-ready formatting, compilation, and compliance of the dossier according to international standards, Pfizer Global Style Rule Book and Style Guide, and PREDICT templates. Document management support for submission-level documents and study reports includes
- Organizing, formatting, hyperlinking, and publishing submission-ready documents and electronic documents and files for CTD and CTA submissions (Nonclinical Overview, Toxicology Tabulated Summaries, Toxicology Written Summaries, Study Reports).
- Requesting, compiling, and verifying published literature references
- Supporting incorporation of CRO study reports into electronic document systems for submissions
- Verification of submission readiness of submission documents (including CRO) Serve as an information resource and point of contact, provide user training and support for new and existing document management tools, and provide continuity of experience and history of practice for document management and submission process. The candidate will also be responsible for nonclinical sections of safety reports which include periodic review of sponsor-initiated studies and literature in the public domain for continuous analysis of relevant nonclinical safety information against current scientific knowledge. Candidate will bring attention to articles of interest to Subject Matter Experts, Clinical and Medical colleagues for evaluation of importance or potential importance to the known safety profile of the product and is responsible to provide a response to WSR within the designated due date.
- The candidate will also partner with WSR to prepare and review correspondence related to nonclinical queries and provide support for nonclinical sections in support of product license renewals.
Candidate Profile :
M. Pharm.,/ M.Sc., in Life Sciences with 0 to 5 year experience
Additional Information:
Experience: 0-5 yrs
Qualification: M. Pharm.,/ M.Sc
Location: Chennai
Industry Type: Pharma
Last date: 5th November, 2016
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