Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our more than 75,000 employees, serving clients in more than 100 countries, as we transform approaches to patient care.
Post : Senior Medical Writer
Job Description
• 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
• Write and 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 RMPs, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
• Act as a writing coach, devise training programs
• Author/review SOPs/WIs/process documents or sections as applicable
• Impart/conduct Trainings for peers and team members
• Coordinate activities related to various types of report writing across a team of writers if applicable
• Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
• Assist in estimation of resource requirement and responding to RFPs as needed
• Internal and external (client) communication & co-ordination to get the required inputs
• Get resolution on issues affecting project deliverables
• Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings
Candidate Profile
Bachelor’s/Master’s degree in Pharmacy / related science area OR Bachelor’s degree in Medical Science
5 years’ experience in the pharmaceutical industry, with at least 3 years of it in medical writing
Experience in drug discovery and pharmacovigilance is desirable
Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Navi Mumbai, Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
Job ID : 232776
End Date : 30th March, 2023
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