Senior Medical Writer

Company: Labcorp
Location: Durham
Posted on: October 12, 2021

Job Description:

Job Overview:

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.

This position is remote based out of the United States or Canada

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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