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’s 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’s discretion on completion of relevant trainings

Apply : https://careers.labcorp.com/global/en/job/2314136/Medical-Writer