Mgr, Medical Writing (R1081723) in Guangzhou, China at IQVIA™

Date Posted: 10/20/2019

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Manage and support the direction of a team of Medical Writing (MW) staff to efficiently produce documents that meet customer requirements. May fulfill the role of site head. May participate in project teams as writing lead and project manager for MW projects.
 Line manager of staff, including Senior MW and Manager level, who may be based at more than one site. Responsible for performance of one or more MW sites.
 Ensures staff have a clear and consistent understanding of the strategy and regional and global objectives; may 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 Quintiles 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.
 May act as Lead Medical Writer on any type of writing project to an exemplary standard and can advise others on any type of document.
 Review and monitors budget for own projects and those 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. Managerial consultation required only in cases of discounts/special rate requests. 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 act as Project Manager for a large stand-alone program, including more than one document type and/or region. May coordinate MW activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
 May lead small global MW initiatives or act as a regional representative on a cross-functional initiative.
 May plan and deliver workshops or presentations on MW topics, e.g. for a conference.
 Keeps abreast of current data, trends, MW and/or technical writing/regulatory knowledge, developments and advances in area of drug development/MW and/or technical writing.
 May draft new cross-functional SOPs (owned by MW). May represent MW as reviewer for cross-functional SOPs owned by other operations.
 Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
 Experienced line manager, with demonstrated success in staff development, engagement, and performance, and sound financial awareness
 Confidence in dealing with most situations with staff without involvement of senior managers
 Successfully builds relationships with managers of other operations and acts as a positive ambassador for MW
 In-depth knowledge of the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
 Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance
 Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of
their results
 Understanding of the time needed to perform routine MW and/or technical writing tasks in order to agree on appropriate
timelines and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget
 Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and
 Demonstrated ability to influence others in global and/or cross-functional or customer discussions. Has earned respect
from peers in other operational groups
 Acts as a positive role model for more junior staff in attitude to customers and colleagues and communication style
 Advanced negotiation skills
 Can identify creative solutions to challenges that are acceptable to Quintiles and customers
 Ability to identify deficiencies, errors, and inconsistencies in documents
 Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical
output as related to acceptance criteria according to SOPs.
 Ability to work on several projects at once while balancing multiple and overlapping timelines
 Ability to assess and prioritize workload
 Demonstrated abilities in collaboration with others and independent thought
 Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other
relevant regulatory agencies (e.g., OECD, MHLW)
 Careful attention to detail and accuracy
 Must be computer literate
 Ability to establish and maintain effective working relationships with coworkers, managers and clients
 Bachelor’s degree in a life science-related discipline, or communications, technical writing, or related field with at least 7
years' broad-ranging experience as a medical/technical writer within a pharmaceutical environment, including extensive
experience in preparing clinical study protocols and/or method validation and study data reports, and including
management experience; or equivalent combination of education, training and experience.
 Extensive use of telephone and face-to-face communication requiring accurate perception of speech
 Extensive use of keyboard requiring repetitive motion of fingers
 Regular sitting for extended periods of time
 May require occasional travel.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1081723