LabCorp Medical Writer Recruitment – B Pharma/M Pharma Apply
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Job Title: Medical Writer
Category Clinical
Location Pune, India
Job Id : 2275994
Job Type Full-Time
Qualifications
Bachelor’s/Master’s degree in Pharmacy/related science area OR Bachelor’s 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
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 Online
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