This role is the primary point of contact for CSR, protocol and disclosure document medical writing and responsibility for multiple therapeutic areas.
Ensures provision of high-quality, compliant deliverables (protocols, clinical study reports, responses to regulatory requests for information, public disclosure, and data transparency deliverables to regulatory authorities worldwide to support the growth of the Pfizer portfolio using the resources from multiple providers.
• This role has responsibility for deliverables across multiple therapeutic areas and business units (GPD, Pfizer Essential Health, Pfizer Consumer Healthcare and WRD) and will establish asset level strategies and services including leading transforming process and practice initiatives.
• This role must be facile in innovative problem solving and demonstrate high levels of function leading through change.
• This role must possess the ability to align and influence peers to move efficiency initiatives forward in alignment with leadership and to communicate effectively with senior management.
This role is responsible for delivery of, creation of processes supporting, and maintenance of staff, including gaining subject matter experts on, Protocols, Clinical Study Reports, Safety and other narratives, Public Disclosure Synopses, Basic Results, and Patient Lay Summaries; and clinical document compliance and Quality Control.
Responsibilities
• Sets medical writing and document compliance (QC) objectives and implements strategies in alignment with department and Business Unit (BU) goals and budget
• Develops effective collaboration with department, BUs, regulatory and other groups to clearly understand requirements and support portfolio goals
• Ensures open communication regarding medical writing status, issue resolution and preventive actions
• Establishes strong partnerships with BU, department leadership, external business partners and others to advance TA portfolio goals
• Anticipates, oversees and influences change to execute efficient, high-quality operational delivery
• Delivers creative solutions to complex problems within and beyond scope of expertise (e.g. TA, discipline, department)
• Manages risk appropriately to enable innovative solutions which maintain timely, quality deliverables
• Partners with customers to ensure clear understanding of needs
• Manages use of resources in line with short, medium and long-term goals
• Manage resources to support current and future needs across multiple projects.
• Delivers a strong talent base within group of within TA writing specialists, preparing for long-term development needs
• Ensures the group is well qualified and encourage further technical and personal skills development to support career progression.
• Develops strategies for managing talent and leadership succession plans
• Influences senior management decisions that have an impact on business direction within the department and functional line
• Aligns and implements efficiency initiatives to improve timelines and delivery of authoring documents end to end throughout the development process.
Qualifications
• At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
• BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the pharmaceutical or biotech industry
• Medical writing and management expertise with a comprehensive understanding of the drug development and reporting process required for study reports and data transparency deliverables
• Experience in people management and talent development
• Extensive knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors
• Experience overseeing multiple medical writing deliverables at various stages across multiple providers
• Demonstrated communication, influencing, project management and negotiation skills
• Knowledge and experience of working across international boundaries and cultures
PHYSICAL/MENTAL REQUIREMENTS
• Position located at GPD site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, participating in global conference calls that accommodate time zones.
• Ability to accurately, comprehensively and professionally communicate both verbally and in writing in the English language.
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