Labcorp – Job Vacancy for Senior Medical Writer- Apply Now
Navi Mumbai, Maharashtra, India
About the job
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
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
Qualifications:
Bachelor’s/Master’s degree in Pharmacy/related science area OR Bachelor’s degree in Medical Science
Experience:
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
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