Sr. Director,Head of China Medical Writing(J22162)社

面议

市辖区

发布时间：2023-09-06

职位描述

工作职责:
Position Purpose
Provides functional area leadership in Medical Writing for ensuring consistent processes and excellence in providing planning and delivery of writing support for clinical study reports, narratives, clinical trial disclosures and for emerging China clinical regulatory documents
Recruits, trains and retains highly skilled workforce of medical writers to support enterprise-wide medical writing projects, with specific focus on early development/clinical pharmacology CSRs, safety narratives and China clinical regulatory writing deliverables, as well as clinical trial disclosures; will explore expansion of the writing deliverables in the team based on evolving portfolio needs and increasing China development activities
As member of the Medical Writing Leadership Team, participates with other Medical Writing leads (Clinical Communications Lead, Clinical Communications TA Leads, Submissions Medical Writing TA Leads) to formulate medical writing strategies and standards and to take responsibility for execution, process improvement and innovation in the discipline
Participates with other Medical Writing leads to take responsibility of resource sharing, staff development, and sharing of best practices
Ensures the Medical Writing China organization meets time, quality, and cost targets consistently with being an efficient and effective business unit
Responsible for supervision, leadership, and management of resources within his/her group to ensure staff are motivated and developed to their full potential and aligned with the needs of the organization
Aligns and motivates staff behind agreed global and local strategic direction, including speed, cost, and quality targets
Mentors and supports staff within her/his group to directly influence and improve project delivery using accumulated experience and knowledge
Ensures excellent customer service through the development of strong working relationships with Medical Writing Leadership Team, biometrics (statistics, programming) colleagues , project teams and local regulatory colleagues to facilitate open communication regarding project priorities and staff development issues
Ensures use of approved technologies that support the business goals
Resources Managed (budget and FTEs)Overall Medical Writing China Team consisting of 35+ Pfizer Colleagues and contractors (this may vary depending upon workload requirements), reporting through ~8 team leads
Budgetary responsibility for Medical Writing China cost center, along with collective responsibility with the Medical Writing Leadership Team for the overall Medical Writing budget
Primary Responsibilities Provides supervision and leadership for the Medical Writing China group
Develops and implements medical writing strategy, focusing on scope of support, optimization of resource pools and operational delivery
Accountable for provision and proactive management of medical writing resources across projects
Ensures that all activities are conducted in compliance with relevant regulatory requirements and SOPs
Implements organizational design and develop succession planning in collaboration with Head of Medical Writing and the Medical Writing Leadership Team
Develops staff, including recruitment, retention, training, and career development to ensure an effective workforce to support projects and to enable staff to realize their full potential within the organization
Works with staff in her/his group to address and resolve performance issues in a timely and effective manner
Initiates career and succession planning to build and sustain longer term capability
Actively participates in Medical Writing leadership team and ensure cross-team collaboration and leadership
Implements strategies to ensure speed and quality in all medical writing activities.
Ensures that staff are trained on all aspects of reporting clinical trial data for clinical studies and are current on medical writing curriculum requirements
Ensures that staff fully understand the requirements of the job and are clear regarding the medical writing deliverables for their protocol/project.
Drives, monitors, and reports on implementation of functional area initiatives
Ensures development and implementation of change management based on worldwide strategies and standards in collaboration with Medical Writing Leadership Team
Works with Head of Medical Writing to administer and manage the group in terms of local HR activities, budget management, application of Pfizer policies and procedures, and other relevant activities
Works with and influences Medical Writing Leadership and other cross-functional group leaders to identify areas for process and technology improvements and develop and implement strategies to address these improvement opportunities
Uses knowledge and experience to work with staff to proactively identify problems on projects and help define solutions
Uses knowledge and experience to support staff in forming innovative options for their activities
Ensures that learnings are shared and applied across teams, and implants strategies to achieve continuous process improvement toward excellence in deliverables
Technical Skill RequirementsDemonstrated knowledge and success in managing multiple clinical programs, and management technologies and processes
Thorough understanding of document repositories and document workflow tools (eg GDMS), collaborative authoring and review platforms (eg PleaseReview, Sharepoint, other systems), data standards and reporting tools. Ability to drive use of new tools such as Immutable Tables, DocFlow, Technology Enabled templates, programmed content creation/auto-generated narratives.
Demonstrated ability to manage complex projects and processes. Established history of timely and quality delivery
Demonstrated knowledge of clinical development and regulatory submission processes and requirements
Demonstrated success/results in prior scientific/administrative management roles
Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations
Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget
任职资格:
Qualifications (i.e., preferred education, experience, attributes)Minimum of a B.S. degree in either a natural/medical science or Business related field
Extensive (>10 years) clinical development and business experience in order to have a thorough understanding of the processes including medical writing
History of achievement in a customer service role with demonstration of meeting customer needs and concerns. History of achievement in building strong customer relationships. Strives to understand and meet customer requirements
Strong technical knowledge of programming and/or writing processes
Leadership, project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both internal and external to the organization
Strong listening skills with the ability to proactively define and manage required communication channels
Preferred Additional ExperiencePost-graduate degree (Masters or above) or overseas university education
Proven experience leading a substantial group responsible for clinical programming and/or clinical writing function, or equivalent
Leadership, project management, resource management (staff and financial), administrative and technical capabilities are required, as well as effective verbal and written communication. International experiences a pl***********************

其他要求

招聘人数：1人
职能类别：

公司介绍

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。