View this video 3:25 min

            
             Send this job to a friend

At Covance, your imagination, your dedication, and your drive to find solutions to challenging projects begin on your very first day. Covance is one of the world’s largest and most respected contract research organizations. Our clients are a Who’s Who of the pharmaceutical and biotechnology industry. If you’re looking for a diverse and stimulating work environment, you'll find it at Covance.

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.

Qualifications:
• 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 experience 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.