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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.

Labcorp Medical Writer Assist Apply Here
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Labcorp Medical Writer Assist Job Openings at Pune
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