• Associate Director, Medical and Regulatory Writing

    Job Location(s) UK-Maidenhead | BE | FR | DE-Berlin | IT | NL-Amsterdam | PL | PT-Lisbon | ES | CZ
    Job Number
    Job Category
    Clinical Operations
    Position Type
  • Job Overview


    Job Summary:


    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 role can be based across various European locations, we are flexible and can consider homebased or office based depending on location and experience.



    Job Duties:

    •       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



    Minimum Required:

    • 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



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