Job Description

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\xe2\x80\x99s 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\xe2\x80\x99s discretion on completion of relevant trainings

Qualifications

Bachelor\xe2\x80\x99s/Master\xe2\x80\x99s degree in Pharmacy/related science area OR Bachelor\xe2\x80\x99s degree in Medical Science

Experience

5 years\xe2\x80\x99 experience in the pharmaceutical industry, with at least 3 years of it in medical writing

Experience in drug discovery and pharmacovigilance is desirable

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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Labcorp