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Labcorp Senior Medical Writer - Remote in Topeka, Kansas

Job Overview:

Senior Medical Writer

Remote: US and Canada

Medical Writers in the Early Phase group typically work on clinical documents for studies in the early phases of clinical development; this includes Phase I through IIa studies focused on safety, pharmacokinetics and pharmacodynamics.

  • Responsible for preparation and coordination of clinical study protocols and clinical study reports (CSRs), and other documents as needed.

  • Provide support for and participate in development of submission level documents under guidance of senior staff.

  • Production of scientific publications and other documents.

  • Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate.

  • Ensure timely delivery of high quality documents to internal customers and Sponsors.

  • Provision and development of intra- and inter-departmental training. Works with the management team to provide guidance and mentoring to Medical Writers to ensure best working practices are maintained.

  • Scientific presentations both internally within Labcorp Drug Development and externally.

  • Represents the company at scientific meetings and meetings with clients.

  • Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Education/Qualifications:

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

Experience:

Minimum Qualifications Required:

  • Typically minimum 4 years medical writing experience including 3 years as medical writing project lead.

  • Current experience writing clinical study protocols and clinical study reports (CSRs).

Minimum Required:

  • Excellent command of written and spoken English.

  • Excellent written and verbal communication skills.

  • In-depth knowledge of MS Word.

  • Excellent organizational and time management ability.

  • Detailed knowledge of ICH guidelines applicable to medical writing.

  • Good understanding of medical/scientific terminology and experience in data analysis and interpretation.

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