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Regulatory Writing Submission Scientist

2.00 to 5.00 Years   Bangalore   04 Aug, 2019
PFIZER LIMITED
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

  • Support and review global regulatory dossier and query response preparation activities in collaboration with RSLs and/or PDM scientists.
  • Apply knowledge of international regulatory standards and expectations to establish and promote best practices in study and regulatory submission documents. Accountable for the quality of nonclinical components of regulatory submission dossiers, query responses and other documents supporting interactions with regulatory agencies.
  • Oversee the timelines and reviews associated with the nonclinical summary documents, and ensure 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.
  • Work within Pfizer s Global Document Management System (GDMS) to manage document preparation, review, and approval.
  • Contribute to preparation of nonclinical sections of annual and aggregate safety reports and product license renewals, including periodic review of scientific literature and sponsor-initiated studies.
  • 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 processes.
  • Lead the team in one or more areas of technical expertise, e.g., regulatory writing, document management, license renewals, and/or safety reporting.
  • Serve as back-up to the RWSS Team Lead in management and oversight of RWSS team and activities
  • Contribute to continuous improvement and career growth for RWSS team
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Keyskills :
documentmanagementsystemdrugsafetyusertrainingmanagementsystemdocumentmanagementdocumentpreparationqualemploymentopptunity

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