AD or Manager Medical Writing - Office based RTP, North Carolina Overland Park Kansas or Homebased
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4 Year Degree
5 to 7 years
At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
DescriptionManage and support the direction of a team of Medical Writing (MW) staff to efficiently produce clinical documents that meet customer requirements. Manage customer relationships by working directly with the customers on medical writing issues, offers proactive solutions and advice to customers.
Primary Duties and Responsibilities:
Line manager of staff, including Senior MW and Manager levels, who may be office- or home-based. The majority of the writers are office-based in RTP, NC.
Ensures staff have a clear and consistent understanding of the strategy and regional and global objectives; contribute to discussions on how to implement strategy on a regional basis. May set and drive site-specific objectives as appropriate. May participate in global MW management activities.
Provides senior review and guidance for most documents prepared by junior staff. May design training materials and input into generic training plans. May plan and deliver general training on MW to other QuintilesIMS groups and externally, as appropriate.
Sets SMART goals and objectives for staff.
Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
Review and monitors budget for projects of direct reports and/or departmental budgets, including out of scope activities, and ensures that revenue is recognized as appropriate. May review and approve costings for majority of projects. Independently prepares and presents slides for MW component of any full-service bid defense meeting; may present on MW and discuss proposals at a stand-alone bid defense meeting.
May coordinate MW activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
Keeps abreast of current data, trends, MW and/or technical writing/regulatory knowledge, developments and advances in area of drug development and MW.
Minimum of Bachelor’s degree in a life science-related discipline, advanced degree preferable, with at least 5-7 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including extensive experience in preparing clinical study protocols and reports, with consistently positive customer feedback; or equivalent combination of education, training and experience.
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