Director - Process and Innovation Lead

Pfizer Inc.

Remote, United Kingdom

Job posting number: #7146933 (Ref:pf-4885800)

Posted: May 25, 2023

Application Deadline: Open Until Filled

Job Description

Product License Maintenance Data Sciences (PLMDS) is a multi-functional organization in Global Regulatory Operations/Global Regulatory Sciences.

The PLMDS Process and Innovation Lead is responsible for a range of research, development, business and process-related initiatives across the PLMDS organization.

The role is broad, covering a wide range of supportive disciplines, and colleagues within the role will specialize in one or more areas depending on business need:

The role is a key driver of innovative thinking in PLMDS, helping create a virtual culture of risk-taking and creativity, and works closely with the Head of PLMDS Functional Leads, PLMDS Managers and CDM Managers  to execute cutting edge innovations and transformative projects.

Leadership of large and medium scale projects to improve efficiency, quality or cost, with equal focus on effective implementation of these projects, using advanced change management and knowledge management techniques.

  

Subject matter expertise in general business process, this role will have awareness of a local regulations. The role sponsors, coordinates and directs process forums and associated continuous improvement efforts to ensure PLMDS processes are efficient and globally consistent.

Championing data quality, verification, connectivity and governance to facilitate understanding and contextualize areas of opportunity. The role has expert knowledge of PLMDS metadata and systems, and their relationship to wider business process and policies, and acts as a facilitator to other support lines to leverage expertise into PLMDS to resolve challenges. 

Development of products, services or approaches which support the smooth functioning of PLMDS and wider business value. Such support may include partnership with Business Operational functions to facilitate full transparency of capital opportunities across the organization, predictive analytics which enhance forecasting ability, and practical return-on-investment (ROI) calculation techniques to support PLMDS. This support is highly integrated and tailored to meet the needs of PLMDS  functions so that the model is optimized to meet customer needs. 

Acting as a Mentor/Coach to peers/colleagues delivering projects including project management, advanced change management and knowledge management techniques.

He/She will have a global view of PLMDS functions, is comfortable working across a range of deliverables from early research investigations, through project design/management, to effective implementation. The incumbent is both an advocate for innovation as well as a champion for quality and delivery.

In addition, this role may include monitoring trends and policy positions in the global regulatory environment that impact PLMDS. Partners with Policy Intelligence to provide seminal analyses of these regulatory trends and communication to internal stakeholders. 

JOB RESPONSIBILITIES

Program management of multi-regional technological, behavioral and process change activities, with particular emphasis on transformational projects.

Leads selected roadmap projects, working with other functions to ensure effective implementation of final solutions.

Participant/lead on Steering groups across selected geographies (Americas, Europe, Asia, Emerging Markets) to progress strategic change related to Labeling processes

Where appropriate acts as subject matter expert on development of standards supporting Industry associations, regulatory agencies (as support to PPLS teams), vendors, and in-licensing partners

Accountable for associated PMO activities for selected roadmap projects including but not limited to provision of metrics dashboards, ROI calculations, Hypothesis testing, predictive modelling, and impact assessments.

Review draft and final regulatory agency regulations, guidelines and regulatory policies. Identify the strategic impact of these regulatory documents to PPLS.

Development of effective knowledge management and communication techniques to organize and deliver training either personally or via network of trusted experts

Prepare environmental analyses to identify emerging regulatory trends and likely future scenarios resulting from emerging trends.  Educates PPLS and stakeholders on key priorities, trends, and changes in the regulatory environment. 

Promotes innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processes; takes appropriate risks to develop innovative ideas/ processes/products.

Fosters an environment that thrives on curiosity

Identifies innovative concepts, translates into processes within PPLS and recommends courses of action to senior leaders that impact PPLS and the wider business.

Working with the PLMDS LT, develops vision, strategy, and performance objectives for the end-to-end processes.

Acts as SME Point of Contact with Information Management (IM), Business Operations Center of Excellence (CoE), Regulatory Policy and other functions on behalf of PPLS.

Exercises foresight and judgment utilizing comprehensive breadth of knowledge and prior work experience

Acts independently on self-initiated projects and leverages knowledge from others related to overall objectives, strateg

y, critical issues and policy matters

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

  • Proven fluency with the use of soft skills and ability to adapt core project management skills successfully within a dynamic line environment.
  • Extensive business experience at required level to enable thorough understanding of the responsibilities associated with strategic pursuit and tactical application of evolving business processes
  • Ability to transform ambiguous situations/discussions into structured outcomes
  • Management of change in partnership with key stakeholders
  • Proven leadership and delivery to time and quality driving highly complex projects to meet evolving business needs.
  • Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.  Excellent knowledge of tools used to design processes and process flows, etc.
  • Proven aptitude in project management and process engineering/re-design
  • Leadership, project management, and highly skilled adaptive verbal and written communication skills in relating to colleagues and associates both inside and outside the organization, across various cultures.
  • Demonstrated accountability, and excellence in interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
  • Demonstrated knowledge of drug development processes, regulatory codes/guidance's, and technologies across ICH regions
  • Demonstrated ability to work with or lead a team in a matrix structure.
  • Experience with XML, Document Management, regulatory milestone reporting tools
  • Ability to synthesize and communicate complex information and analyses to a variety of audiences in both verbal and written format
  • Ability to extract critical information and prepare succinct summaries of regulatory documents, including assessment of the potential impacts to Pfizer.
  • Ability to conduct regulatory metrics analyses, and regulatory trending and impact analyses.
  • Ability to easily navigate information databases and health authority websites to gather necessary information.
  • Understanding the global regulatory environment and its impact on BU strategies.
  • Background in medical or technical writing
  • Highly skilled at identifying the potential provided by innovative thinking, concepts or technologies and translating these into opportunities across the spectrum of labeling processes
  • Comfortable operating and leading in a risk-taking environment, striving for transformational gains while conscious of regulatory risks in different regions. Capable of cutting through complexity to deliver simple solutions with decisiveness and clarity.
  • Anticipating internal/external business and regulatory/ compliance issues that impact  PLMDS
  • Have foresight and judgment in complex decisions and troubleshoots in ambiguous situations in PLMDS
  • Have the ability to influence senior management decisions that impact business direction

Education:

  • Bachelor's Degree or equivalent preferred
  • Advanced academic qualification/degree is desired but not required.

Experience:

  • Strong experience in global/multi-national pharmaceutical environment, including direct experience either in Labeling, Regulatory Submissions, or Regulatory Affairs role.
  •  Experience in ability to function autonomously at senior levels and in a matrix team environment a must.
  • Experience in interpreting and applying global and local regulatory guidance around labelling and associated supportive documentation are desirable but not required.
  • Experience in identifying, driving and implementing innovative solutions

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Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Regulatory Affairs

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Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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More Info

Job posting number:#7146933 (Ref:pf-4885800)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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