Assoc Dir, Med Writing

Covance Inc.Great service, exceptional growth!

As a billion dollar company with widespread global reach, Covance's ability to offer integrated drug development services is unsurpassed. Covance has achieved impressive growth by fostering a work environment that encourages, develops and leverages our team?s capabilities. Covance is committed to that mission - to cultivate the varied skills, cultures, ideas and experiences of every employee around the globe. There is no better time to join us!


The global Regulatory Services Center of Excellence is responsible for ensuring that work undertaken by Covance Late Stage Development Services meets the requirements of government regulatory agencies locally and worldwide. This responsibility includes the preparation of a variety of clinical documents including clinical study reports for Phase I to IV clinical trials run by Covance globally, in collaboration with other Covance units as necessary. It is the responsibility of the Associate Director, Medical Writing to prepare such documentation to the required standard in a timely fashion. The Associate Director is also responsible for providing this service and associated advice to clients. The Associate Director is expected to acquire a competency in the use of Documentum and associated tools.


Job Duties and Responsibilities (including supervisory)To carry out all activities in accordance with Covance Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP)To record all project activities accurately on company standard timesheetsTo lead the Medical Writing group as well as Medical Writing contractorsTo track all Medical Writing tasks and documentsTo assign Medical Writers to projects and balance resource needsTo review documents as needed to provide oversight for quality and contentTo prepare documentation for regulatory submissions (eg, protocols, clinical study reports, and summary documents) in collaboration with Clinical Research, Medical and Statistical personnel (as appropriate) to client and/or Covance specificationsTo prepare regulatory documents in Common Technical Document (CTD) formatTo have general knowledge and familiarity with electronic publishing and writing requirements for compliance with the publishing systemTo provide advice and support for electronic publishing including Time & Cost EstimatesTo be responsible for project coordination, as appropriateTo prepare and/or review global SOPs, as necessaryTo consult with project teams and clients to develop strategies and timelines for organizing and preparing clinical study reportsTo consult with project teams and clients to develop strategies and timelines for organizing and preparing CTDs, New Drug Applications (NDAs), and other summary documentsTo provide advice on both local and global Medical Writing issues to project team members (internal and external to Covance) and help to resolve problemsTo prioritize and forward plan workload to a high standard; to advise Senior Management of significant problems promptlyTo provide oversight review including edits and comments on reports generated within Covance or by client companiesTo chair or participate independently in client meetings, as appropriate.To provide advice and support for Business Development personnel regarding Time & Cost Estimates, as requestedTo build and maintain good Medical Writing relationships across functional unitsTo regularly demonstrate initiative and ability to deal with complex and difficult situations independentlyTo develop and implement ideas to improve the effectiveness and efficiency of the jobTo assist Senior Management to assess functional operations and plan for new proceduresTo assume line management responsibility for nominated staffTo assist in the development and presentation of relevant training courses for Medical Writers and other Operational Staff, as requestedTo undertake any activities involving communication with others, internally and externally, as requestedQualifications
Required:Minimum 4-year degree in Life SciencesApproximately 10 years' experience in the preparation of clinical documentationApproximately 5 years' managerial experience in the area of medical communicationsExperience with regulatory submissionsExperience in data handling and data analysisExperience in writing and editing regulatory documentsGood written and verbal communication skillsAbility to write fluent and grammatically correct English with an appreciation of the differences between UK English and American EnglishGood word-processing skillsGood organizational and time management skillsPays attention to detail
Ability to work to tight timelines while maintaining accuracyAbility to work to a variety of client-driven specificationsGood team playerFamiliarity with Quality Assurance and Quality Control proceduresGood overall knowledge of the clinical trial process and GCP including international regulatory requirements for the conduct of clinical development programsAppreciation of the business requirements of a contract research organizationThe Associate Director may be required, albeit infrequently, to travel and stay away from home for short periods (less than 10%)Flexibility in the standard working hours may be requiredAt Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is well-positioned for continued growth!
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Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
REQUIREMENTS
Please see Job Description