Job Description
Seeking a Regulatory writing submission scientist (RWSS) who will liase with Drug Safety Research & Development (DSRD) Regulatory Strategy Leads and Medicine Design/PDM colleagues to prepare and support the expert nonclinical sections (pharmacology/ADME/toxicology) of regulatory dossiers and oversee the integration of all nonclinical contributions.
Job Title/Position:
Associate Scientist
Job Overview:
Job vacancy for Pharmacy, Life Science
Job Location:
India – Chennai
What are the Key Responsibilities?
The RWSS colleague will support global regulatory dossier and query response preparation activities in collaboration with the Regulatory Strategy Leads (RSLs) and/or PDM scientists. The RWSS colleague will also oversee the timelines and reviews associated with the nonclinical summary documents and will be 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 and formatting submission-ready documents and files for regulatory submissions (Nonclinical Overview, Nonclinical Tabulated Summaries, Nonclinical Written Summaries, Study Reports)
- Working within Pfizer’s Global Document Management System (GDMS) to manage document preparation, review, and approval
- Requesting, compiling, and verifying published literature references
- Supporting incorporation of CRO study reports into GDMS
- Verification of submission readiness of submission documents (including CRO)
What are the Educational Qualification(s) for this position(s)?
A minimal Bachelor degree in Pharmacy /Life Science is required.
What are the Preferred Skills required for this Job/Position?
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. RWSS colleague will bring attention to articles of interest to Subject Matter Experts, RSLs, and/or PDM scientists 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.
The candidate will 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.
The candidate will apply knowledge of international regulatory standards and expectations to establish and promote best practices in study and regulatory submission documents. The candidate will be accountable for the quality of nonclinical components of regulatory submission dossiers, query responses and other documents supporting interactions with regulatory agencies.
Must have an intermediate or advanced level of knowledge in writing, analytical skills, and communication. Demonstrated abilities in influencing and negotiating and competency in managing work schedules and deadlines. Some experience in nonclinical toxicology aspects of drug development, or regulatory submissions is desirable.
Related:
Opportunity for pharmacist at Odisha State Medical Corporation Limited (OSMCL)
