Senior Medical Writer
Remote in the United States or Canada
Medical Writers in the Early Phase group would 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 Covance 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.
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
Minimum Qualifications Required: