Associate Scientist

2 days ago

Chennai, India Pfizer Full time

Why Patients Need You

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. 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)

QUALIFICATIONS / SKILLS

A mínimal Bachelor degree in Pharmacy /Life Science is required.

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.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Research and Development

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