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Job Description:
Prepares protocols, CSRs and manuscripts including interpretation of clinical data and statistical results as appropriate
Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs
Prepare and review patient safety narratives
Leads project management and coordination of narrative projects
Oversee and coordinate other writers on CSR appendices compilation
Prepare documents in accordance with Labcorp/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
Incorporates internal and/or external review comments on clinical documentation
Prioritize and forward plan workload to a high standard; to advise Management of problems promptly
Participate independently in internal and external client meetings. Lead meetings as appropriate
Responsible for project coordination and adherence to project timelines and budget
Identify ways to improve the efficiency and quality of work processes
Mentor Associate Medical Writers and Medical Writer I, as appropriate
Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience
Provide training to Medical Writers and other staff as appropriate
Represent department in audits and inter-department working groups
Comply with labcorp internal processes and procedures
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.
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