Global Regulatory Affairs (GRA) Job Description (JD)

Job Title:

Publishing Project Lead

Organization

Global Product Development (GPD) / Global Regulatory Affairs (GRA)

Line (if applicable)

Global Regulatory Operations (GRO)

Department/Group (if applicable)

Publishing and Product License Support(PPLS)

Region and/or Country (if applicable)

China

Version Date:

DD- MMM-2019

Organizational Relationship(s) including to whom the position reports (JD Job Title):

China Publishing Hub Lead

Position Purpose

This Publishing Project Manager role will have accountability and oversight of PPLS publishing regional and global operational initiatives and a vendor sub-team in other APAC region, which applied ensuring a continuous improvement of Pfizer delivers on key regulatory milestones and maintains compliance with applicable obligations. This is a manager position following P Track.

Primary Responsibilities

The publishing project manager provides comprehensive project management for Global Publishing operational initiatives to ensure alignment and execution among Publishing, Submission Management, Information Management, and Business Technology, etc. This person serves as the program operational leader ensuring all cross functional deliverables are achieved on or ahead of schedule, within budget target, and with quality that meets or exceeds business needs. The Publishing PM’s responsibilities include but not limited to strategic preparation, scenario planning, testing and execution, team effectiveness, resource management, risk management, and communication management. The Publishing PM needs to have comprehensive understanding of the governance process, strategic planning, and the foundational tools that support planning, communication, and continuous improvements in the area of operational delivery.

Key Accountabilities:

• Support the key delivery of PPLS global publishing portfolio
• Oversee and active supervision of a project team within Pfizer and/or vendor sub-team in other APAC region.
• Drive creation and maintenance of publishing project management plans, including goal specification, documentation, and communication to staff, periodic review/refresh and tracking key delivery against stated goals.
• Management and/or execution of selected non drug activities and initiatives, involving proactive liaison with stakeholders across the Pfizer organization, prioritizing and executing to meet deadlines and objectives with activities related to strategic project tracking, finances, resource management and vendor management, etc.
• Drive/support resource and workload assessment via portfolio demand activities and algorithms.

Technical Skill Requirements

• Strong understanding of the concepts around regulatory affairs and significant knowledge of drug development and regulatory submissions processes.
• Demonstration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
• Demonstrated ability to work with or lead a team in a matrix structure.
• Ability to quickly understand, assess and adjust process in support of quality, compliance and efficiency.
• Leads change.
• Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
• Proven ability to work successfully on global or local virtual team, and must be good working under pressure and be good at time management.
• Strong sense and proven ability in process deep diving, re-designing and optimization.
• Articulate with strong analytical and interpersonal skills.

Qualifications (i.e., preferred education, experience, attributes)

• Bachelor or Master Degree in Pharmacy, Life Sciences, Business or Information Technology (desirable).
• 5+ year experience working in pharmaceutical industry for Regulatory Affairs, Regulatory Operation, Project Management etc.
• Well organized, creative, independent, self-motivated individual with strong project management skills.
• Provides leadership in a wide variety of areas and situations, facilitates the exchange of information between parties, ensures that aims and objectives are being met and understood.
• Ability to understand and analyze business data to generate information and actions.
• Anticipates situations and problems and takes initiative.
• Demonstrated excellence in interpersonal (verbal and written) skills
• Expresses ideas and information clearly, creatively and persuasively when speaking, in writing, and when making presentations at local and global forums.
• Robust understanding of biopharmaceutical industry, regulatory submission processes and ICH guidance, eCTD and Advanced Technologies (Artificial Intelligence, RPA etc.)
• Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.

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