Labcorp Medical Writer Assist Job Openings at Pune
Labcorp hiring Notification for Medical Writing Assistant
Position : Medical Writer Assist
Department : Clinical Development
Location : Pune
Job Description :
Implement and promote the 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 documents, 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, the author proposed label text, and prepare supporting/justification document
Author/review SOPs/WIs/process documents or sections as applicable
Impart/conduct Training for peers and team members
Any additional activities as per the project requirement or manager’s discretion on completion of relevant training
- 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
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
