Job Description

Your new employer is Labcorp Drug Development, the world's most comprehensive drug development company, dedicated to improving health and improving lives. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow's challenges as they evolve. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

Exciting opportunity for a Medical Writer to join our Medical Device and Diagnostic Development division on a full-time and permanent basis.

Your main responsibilities will include but not be restricted to:

Prepares protocols and CSRs, 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.

Education/Qualifications

Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.

Experience

Typically minimum 3 years' medical writing experience including 1 year as medical writing project lead.

Excellent command of written and spoken English.

Good written and verbal communication skills.

In-depth knowledge of MS Word.

Good organizational and time management ability.

Excellent interpersonal skills.

Scientific or clinical research experience desirable.

Good scientific writing skills.

Knowledge of ICH guidelines applicable to medical writing.

Understanding of medical, pharmacokinetic and statistical principles.

Get ready to redefine what's possible and discover your extraordinary potential at Labcorp Drug Development. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us and discover why Labcorp Drug Development has been named by Fortune Magazine as one of the World's Most Admired Companies 2022 for the fourth consecutive year, by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.

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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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