Principal Safety Writer

Labcorp Drug Development

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

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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 Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience 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 document, ACOs, Addendum reports
- Author/ review Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned
- Author/ review Investigator Brochures, Protocols, Informed Consent Forms (ICFs), and Case Report Forms (CRFs)
- Author/ review manuscripts, abstracts, posters for conferences
- Prepare/review medical information responses for HCPs
- 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
- Liaise with client and act as a primary point of contact for all report writing activities
- 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
- Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides
- Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document
- Any additional activities as per the project requirement or manager’s discretion on completion of relevant trainings

**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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