Job Description

Job responsibilities 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 Efficiency in conducting literature searches for authoring various types of reports Author/review various safety reports (or part of such reports) for global regulatory submissions for Labcorp\xe2\x80\x99s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned. Perform/review Signal detection activities Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports Perform allied activities like: Generation of line listings and summary tabulation, CFIs CFCs Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document Author/review SOPs/WIs/process documents or sections as applicable Impart/conduct Trainings for peers and team members Any additional activities as per the project requirement or manager\xe2\x80\x99s discretion on completion of relevant trainings Qualifications Bachelor\xe2\x80\x99s/Master\xe2\x80\x99s degree in Pharmacy/related science area OR Bachelor\xe2\x80\x99s degree in Medical Science Experience At least 3 years of experience in the pharmaceutical industry, with at least 2 years of it in medical writing 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. For more information about how we collect and store your personal data, please see our Privacy Statement.