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Senior Medical Writer-Maidenhead

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

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.

This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner.

About the Job
The Global Medical Writing department prepares documents for submission to medical regulatory authorities around the world, and is responsible for ensuring that work undertaken meets the requirements of those government regulatory agencies. This responsibility includes the preparation of a variety of clinical documents including protocols and clinical study reports (CSRs) for Phase II/III clinical trials run by Covance globally, in collaboration with other Covance units as necessary. It is the responsibility of the Senior Medical Writer to prepare such documentation to the required standard in a timely fashion. The Senior Medical Writer is also responsible for providing associated advice to clients across the EU region. Responsibilities for this position will include:

Preparing documentation for regulatory submissions (e.g. investigator brochures, protocols, and CSRs) in collaboration with Clinical Research, Medical and Statistical personnel (as appropriate) to client and/or Covance specifications
Working directly with client Medical/Statistical teams to plan and develop CSRs and higher level regulatory submissions (e.g. Common Technical Document (CTD) Summaries)
Responsibility for project coordination, as appropriate
Providing advice on both local and global Medical Writing issues to project team members (internal and external to Covance) and help to resolve problems
Prioritising and planning of workload to a high standard; to advise Senior Management of significant problems promptly
Providing advice and support for Business Development personnel regarding Time and Cost estimates, as requested
Reviewing and commenting on reports generated within Covance or by client companies
Participating in client meetings, as appropriate
Building and maintaining good Medical Writing relationships across functional units
Assisting Senior Management to assess functional operations and plan for new procedures
Assisting in the development and training of Medical Writers and other Operational Staff, as requested

About You

A relevant science degree; A PhD is desirable but not essential
Good overall knowledge of clinical trial process and GCP including international regulatory requirements for the conduct of clinical development programs
Experience in the preparation of clinical documentation
Knowledge of appropriate Regulatory guidelines
Experience in data handling and analysis
Excellent written and verbal communication skills
Ability to write fluent and grammatically correct English with an understanding of Medical and Scientific terminology and procedures
Good word processing skills
Good organisational and time management skills
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
MAA experience a definite plus

We Offer

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.

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.

There is no better time to join us!

Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.

To apply for this position please apply directly to the Covance website www.covancecareers.com quoting the ref no:31988