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WHAT
IN
Manager Medical Writing
Job
Covance
US
-
Princeton,
New Jersey
Job Code - 16363BR
Position - Full-Time
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Covance for this position!)
JOB DESCRIPTION: Manager, Medical Writing
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us!
Exciting career in Medical Writing!
Currently we have an opportunity for a Manager, Medical Writing.
The Manager of Medical Writing is expected to lead the regional medical writing team to deliver high quality regulatory documents that meet ICH standards, project timelines, and client specifications. This position is accountable for the training/mentoring of the junior medical writers, developing relationships with clients and other departments, and supporting new business development in medical writing. The responsibility of the Manager of Medical Writing includes the management and preparation of a variety of clinical documents including protocols, clinical study reports, narratives, and investigator brochures for Phase I to IV clinical trials run by Covance globally. The Manager of Medical Writing is also responsible for preparing clinical summary documents, including Integrated Summaries of Safety and Efficacy for NDAs and MAA in eCTD format. The Manager is expected to acquire a competency in the use of Documentum and associated electronic publishing tools.
REQUIREMENTS - QUALIFICATIONS: Manager, Medical Writing
• BA or BS in life sciences with minimum 10 years relevant medical writing experience, MS in life sciences with minimum 8 years relevant medical writing experience, or PhD in life sciences with 5 years minimum relevant medical writing experience.
• Managerial in overseeing the work and career development of a team of medical writers.
• Medical writing expertise in the preparation of clinical documentation (ie, protocols, CSRs, narratives, investigator brochures, ISE/ISS, and eCTD clinical summary documents).
• Experience in data handling and data analysis
• Good written and verbal communication skills
• Ability to write fluent and grammatically correct English with an appreciation of the differences between UK English and American English
• Good word-processing skills
• Good organizational and time management skills
• Pays attention to detail
• Ability to work to tight timelines while maintaining accuracy
• Ability to work to a variety of client-driven specifications
• Good team player
• Familiarity with Quality Assurance and Quality Control procedures
At 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 committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Covance
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