Spec I Pss

3 weeks ago


Navi Mumbai, India Labcorp Full time

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
 Ensure compliance of operations with governing regulatory requirements
 Create, maintain and assume accountability for a culture of high customer service

 Write various safety reports (or part of such reports) for global regulatory submissions for Labcorp's clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
 Write Investigator brochures and sections of protocols
 Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
 Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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