Pfizer Director, China Medical Writing Head in Shanghai, China

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 Requirements

  • Demonstrated 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

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 Experience

  • Post-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 plus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.