Manager， Medical Writing / IQVIAサービシーズ ジャパン株式会社
|職種||Manager， Medical Writing|
・ Line manager of staff， typically below Senior Medical Writer level and probably based at one site. Responsible for performance of direct reports (quality， profitability， utilisation). May be responsible for performance of a small MW site.
・ Works with senior management to understand and interpret SBU strategy and effectively communicates strategy to direct reports. Ensures objectives of individual staff are in line with the overall MW objectives.
・ Acts as Lead Medical Writer on any type of writing project， with limited guidance from senior staff， and consistent high quality and efficiency. Can use experience and initiative to tackle new/unusual document types and customer requirements.
・ Reviews and monitors budget for own projects and those of direct reports， including out of scope activities， and ensures that revenue is recognised as appropriate. Can provide independent review of budgets and costings for routine projects. Proposes costings for less routine projects， out of scope activities， and potential budget efficiencies， with guidance from manager. May present on project-specific MW proposals at a full-service bid defense meeting (e.g. managing a series of projects to ensure consistency)， with management input to slides as required.
・ May provide 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.
・ May act as Project Manager for a small series of stand-alone MW projects (e.g. series of related CSRs). May coordinate MW activities for a series of full-service projects， with attendant focus on efficiencies， consistency， budgetary concerns， client liaison， and tracking.
・ May represent region or site on a MW initiative or cross-functional initiative.
・ Keeps abreast of current data， trends， MW/regulatory knowledge， developments and advances in area of drug development/MW.
・ May propose revisions to SOPs or suggest process improvements for consideration. May draft new MW SOPs for review and act as reviewer for MW SOPs， as assigned and 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; rewa
|求める経験||・ Excellent standard of written English. Ability to communicate fluently and effectively with colleagues and customers in English， both in writing and verbally Ability to see the 'bigger picture' and promote this to staff
・ Developing abilities to deal with personnel issues， staff expectations， conflict management
・ Ability to provide fair， timely， appropriate and constructive feedback and guidance to staff
・ Confidence and appropriate communication in representing staff issues or concerns to senior management
・ Confidential and sensitive approach to earn trust of staff
・ Acts as a positive role model to staff in attitude to， and dealings with， colleagues and customers
・ In-depth knowledge of the structural and content requirements of clinical study reports， protocols， and similar documents
・ 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 and interpretation of their results
・ Understanding of the time needed to perform routine MW tasks， agree appropriate timelines， and provide accurate resource estimates and costings.
・ Knowledge and understanding of necessary budget assumptions
・ Ability to give a presentation to a project team and/or customer on project-specific topics， with an air of competence and authority
・ Ability to identify deficiencies， errors， and inconsistencies in documents
・ Ability to effectively review a statistical analysis plan
・ Ability to identify deficiencies， errors， and inconsistencies in statistical output
・ Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and direct reports
・ Confidence in raising and discussing more sensitive topics without management intervention
・ Confident and effective chairing of small to medium-sized meetings
・ Ability to understand the customer's point of view and proactively address customer concerns
・ 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 MW
・ Careful attention to detail and accuracy
・ Must be computer literate
|年収||840万円 - 1260万円|