Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
Post: Principal Scientist Nonclinical Safety
JOB DESCRIPTION:
THE POSITION:
Represent nonclinical safety in EPD Development, responsible for scientific content and compliance with relevant guidelines of nonclinical safety contributions to EPD Development projects, regulatory submissions and authority interactions.
CORE JOB RESPONSIBILITIES:
- Provide scientific support to further development of established products in the area of nonclinical safety.
- Represent Preclinical in project teams and workstreams as needed. Give scientific advice to project teams, development workstreams, Regulatory function colleagues, and EPD Development management.
- Provide expert statements to authorities on nonclinical aspects of established products.
- Prepare/update nonclinical part of regulatory documents (e.g. dossiers, IBs, SPC) for established products.
- Propose, initiate, monitor and report nonclinical safety studies of established products.
- Participate in scientific peer review of Preclinical team output. Risk assessments regarding impurities and extraneous matters in established pharmaceuticals as well as products from other Abbott divisions
- Represent nonclinical safety and provide scientific advice and support to Pharmacovigilance, SMA, DPD and Regulatory Affairs
- Coach and supervise other scientists in the Nonclinical Safety group of EPD Preclinical, initiate and steer regular team meetings, ensure scientific peer review of team output.
POSITION ACCOUNTABILITY / SCOPE:
* Reports to Director Preclinical Development
* Represents Abbott/EPD in interactions with regulatory authorities
* Represents EPD Preclinical in interactions with many functions in EPD
* Ensures adequate and timely preclinical support for all EPD established products
* High responsibility for patient and employee safety
* Major impact on “recall” decisions of already delivered batches in case of impurities/extraneous matter.
MINIMUM EXPERIENCE / REQUIREMENTS
Broad expertise and >5 years experience in preclinical R&D, experience in interactions with regulatory authorities, high level of ethical autonomy, proven ability to supervise/coach teams of scientists
EDUCATION:
Ph.D. (or equivalent) in a relevant area of Life Sciences and proven scientific expertise in all areas of nonclinical safety.
Additional info:
Qualification: P.Hd, Life Science
Experience:5+ years
Location: Mumbai
Job Type: Clinical Research-Other
Industry type: Pharma
Click here: Apply Online
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