Job Overview :
Senior Manager, Medical Writing
Remote-Based in the United States or Canada
Responsible for the administration, organization and management of the staff in the Medical Writing department (Early Phase or Phase 1).
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.
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.
Assist management in assessing department needs and developing new procedures and services.
To deputize for the Head of Medical Writing or designee, if so requested.
Education / Qualifications :
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
Minimum Qualifications Required :
3 years of current direct line management experience.
3 years of current early phase development or phase I exposure.
Minimum Experience Required
Typically, a minimum of 10 years of related experience, including experience in early phase or Phase 1.
Good people management skills and supervisory skills, preferably gained from a minimum of 5 years of 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 guidance’s.
Excellent understanding of medical / scientific terminology, data analysis and interpretation.
Strong appreciation of the business requirements of a contract research organization.