Medical Writer II

Job Overview:

Medical Writer II

Remote in the United States or Canada

Full-Time  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 (e.g., abstracts, posters, manuscripts, etc.). Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Lead and coordinates activities of other writers on higher complexity narrative projects. Ensure timely delivery of high quality documents to internal customers and Sponsors. Provision and development of intra- and inter-departmental training. Work with the management team to provide guidance and mentoring to Medical Writers to ensure the best working practices are maintained. Scientific presentations both internally within Covance and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Develop 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. 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 Covance/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:

Minimum Qualifications Required: Experience writing clinical study protocols & clinical study reports. Project lead experience.

Minimum Required: 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. 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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