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Principal Medical Writer

Company: Covance
Location: Durham
Posted on: May 17, 2019

Job Description:

Principal Medical Writer Job Overview A career at Covance provides our employees the unique opportunity to make an immediate impact and difference in our patient's lives. Joining Covance will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting. Our mission is to help our clients bring the miracles of medicine to market sooner. We are currently hiring a Principal Medical Writer. This position can be home or office based in the US. Responsible for preparation and coordination of complex scientific publications documents (e.g., abstracts, posters, manuscripts, etc.). and/or clinical study protocols and clinical study reports (CSRs), or other documents as needed. May be responsible for preparation of submission level documents. Provide review and feedback on documents prepared by the department. Performs the scientific review of publications documents, clinical study outlines, protocols, statistical analysis plans, tables, figures and listings, and CSRs, ensuring high scientific integrity and correct data interpretation where applicable for all of these products. Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate. Provides technical leadership with responsibility for delivering Medical Writing Services to clients and internal Covance project teams. Ensure timely delivery of high quality documents to internal customers and Sponsors. Scientific presentations both internally within Covance and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Works with the management team to provide project leadership, guidance, mentoring and training to Medical Writers to ensure best working practices are maintained. 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. Produce scientific papers, abstracts and/or posters, and presentations. May also write and coordinate the development of protocols, CSRs or other clinical documents of any complexity Takes the lead in preparing submission level documents Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines and budget requirements Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines Act as medical writing lead and liaison for major clients and partners Represent company at scientific and medical writing forums Keep up to date with developments in Medical Writing Demonstrate detailed knowledge of Medical Writing industry requirements such as ICH and regulatory agency guidelines To regularly demonstrate initiative and ability to deal with medical writing situations independently. Present solutions and convince management and teams to adopt recommended strategies Lead Medical Writing initiatives to develop and improve processes, including new technologies. Persuade other department staff to accept and embrace new working practices Mentor staff and provide guidance and training to department Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences Write and review Covance SOPs and associated documents Represent department in audits and inter-department working groups Comply with Covance internal processes and procedures Performs other duties as assigned by Management Education/Qualifications Recommended: Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred Experience Minimum Required: Typically minimum 6 years medical writing experience, including 3 years as medical writing project lead 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 Excellent knowledge of ICH guidelines applicable to medical writing and other regulatory guidances Excellent understanding of medical/scientific terminology, data analysis and interpretation Appreciation of the business requirements of a contract research organization

Keywords: Covance, Durham , Principal Medical Writer, Healthcare , Durham, North Carolina

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