Associate Scientist Rwss Job In Pfizer Asia Pacific Pte Ltd In Chennai, India

Why Patients Need YouPfizer's purpose is to deliver breakthroughs that change patients' lives Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the worldSeeking 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 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)

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 dateThe 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 renewalsThe 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 agenciesQUALIFICATIONS / SKILLSA minimal Bachelor degree in Pharmacy /Life Science is requiredMust 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

• Work Location Assignment:Hybrid

Work Location Assignment:FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operatesResearch and Development#LI-PFE

Pfizer Asia Pacific Pte Ltd is looking for .

Pfizer Asia Pacific Pte Ltd is looking for Any Graduate / Post Graduate profile candidates.