Covance Associate Director, Medical and Regulatory Writing in Maidenhead, United Kingdom
Management of direct and indirect reports. Oversee resource planning and project assignments. Oversee medical writing processes and projects to ensure production of high quality deliverables. Provides medical writing leadership and advice to clients and internal Covance project teams. Support client and business development activities. Provide review and feedback on documents prepared by the department.
This is a UK based role, and can be homebased or office based depending on location and experience.
Participate in staff assignment discussions and make recommendations as appropriate
Monitor staff to ensure internal and external deadlines are met
Ensure staff are adequately trained and can perform the duties assigned
Identify development needs for staff and department including development and delivery of training
Manage performance reviews of direct reports
Provide input into salary reviews for direct reports and nominate for promotion when ready
Demonstrate ability to manage complex and difficult situations independently
Identify and resolve problems related to the production of deliverables
Ensure the processes used in the production of deliverables are followed and documented as appropriate
Provide review and feedback on deliverables prepared by medical writing staff
Prepare and/or review global SOPs, as necessary
Constantly look for ways to improve the efficiency and quality of work processes
Establish and maintain strategic client relationships.
Build and maintain good relationships across functional units in Covance
Support corporate business development and marketing activities including proposal input, client presentations and professional seminars
Maintain awareness of new developments in Medical Writing and in the global regulatory environment which may be applied to the management and reporting of clinical trial data
Provide input into budgetary requirements, perform ongoing financial review of projects, ensure that all issues are highlighted and resolved as quickly as possible and that all non-contract tasks are identified, tracked and included in change order forms.
Assist management in assessing department needs and developing new procedures and services
Support the Executive Director Medical Writing on short- and long-term strategies to improve processes in Medical Writing.
Education / Qualifications
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred
Typically minimum of 12 years related experience.
Good people management skills and supervisory skills, preferably gained from a minimum of 5 years line management or supervisory experience.
Excellent command of written and spoken English
Excellent written and verbal communication skills
Excellent 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
Good appreciation of the business requirements of a contract research organization
Job Number 2018-20181
Job Category Other
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.