AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare. Backed by strong science and wide-ranging commercial skills, we are committed to sustainable development of our business and the delivery of a flow of new medicines that bring benefit for patients and add value for wider society.
Post : Clinical Pharmaceutical Physician
Job Description
- Is responsible for medical/Global medicines Development (GMed) components of periodic reports such as Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) and annual New Drug Application (NDA) reports, license renewals, labeling and regulatory responses(in collaboration with other team members) under the direction of the Global Clinical Leader (GCL) or delegate Senior Medical Lead (SML)
- Works with international colleagues and with external Alliance partners on on regulatory requests/issues
- Applies strategic intent of AstraZeneca when working with Alliance partners and Regulatory Authorities
- Able to serve as a source of medical expertise for the Product Team
- Able to provide guidance for investigator initiated trials in cooperation with regional marketing companies
- Able to act as Global Clinical Leader delegate on assigned tasks.
- Is accountable to GCL (or delegate) and GMed leadership for identifying risks and proposing mitigation strategies to enable a successful execution of License-to-Operate tactics
- Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws
Candidate Profile
Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent.
Fluent in oral and written English
≥3 years clinical research expertise in relevant therapy area or CRO experience
Good knowledge of biostatistics, global regulatory environment and pharmacovigilance
Proven teamwork and collaboration skills
Good presentation skills. Can communicate effectively with internal and external collaborators
Additional info:
Location: Karnataka
Job Type: Clinical Development
Industry type: Clinical Pharmaceutical
Click here: Apply Online
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