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Translations and Dossier Excellence Senior Manager

Pfizer


Location:
Sandwich, MA
Date:
11/22/2017
2017-11-222017-12-23
Pfizer
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Job Details

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



Reports to Head of Translations and Dossier Excellence within Submissions Management in Worldwide Safety & Regulatory.







Networks with WSR colleagues across locations, manages contract /project and / or vendor resources as appropriate and works with key internal interfaces; Finance, Procurement, and other relevant WRD stakeholders.







**Position Purpose**



To drive process standardization, excellence and change specifically related to Submission Management, whether driven by improvement or change in operating model; capturing and analyzing areas for improvement and implementing remedial action on designated business processes.







To set and promote the framework for inspection readiness with regard to submission processes, and to champion compliance with internal requirements and external regulations







The emphasis of this role is overseeing performance of submission / dossier processes across multiple regions and/or HQ. Management of business performance is global, cross-regional and/or within region in line with priority business need.







To monitor delivery of expected process efficiency and identify opportunities for enhancements based on metrics and stakeholder feedback.







This role operates as primary point of contact for dossier and translations excellence, working across multiple functions and may represent the line on multiple change projects in this capacity.







**Primary Responsibilities**







**Performance and Data Quality Oversight**







+ Define, generate and maintain high quality translation and dossier execution performance and productivity metrics including any relevant user interface and customer support providing expert input to respond directly or indirectly to business questions.



+ Liaise with business stakeholders to define, design and implement performance measures.



+ Ensure performance measures are supported by robust business rules and practices across the global organization.



+ Serve as an expert resource for evaluation and action against assigned measures.



+ Share best practices with the broader WSR business community.



+ Analyze metrics to get a clear understanding of current performance and trends and applies sound decision-making; monitoring adherence against established service level agreements or business practices, providing information, analyses, business insights, and recommendations.



+ Ownership of issue resolution through execution or oversight.



+ Identification, lead and implementation of report changes through improvements, or project output including project success measures.



+ Provide briefing material and input to global or local leaders including recommendations or readouts of lessons learned / CAPAs.



+ Resulting from performance measurements analysis, identify opportunities for improvement in goal delivery, qualitative assessments for the strategic objectives/initiatives underpinning improved operational execution.



+ Act as subject matter expert on development of metric solutions, visualizations and key performance indicators, operating as point of escalation for peers and delegate for SM leadership as required.



+ Drive decision-making by providing business insights and recommendations in addition to information and analyses. **CI Oversight:**







+ Effectively contribute or lead implementation of continuous improvement, across relevant business lines and external providers.



+ Lead or support analysis of improvement programs and potential results.



+ May facilitate improvement teams.



+ Maintain performance metrics to measure program success.



+ Operate as Subject Matter Expert in assigned field with responsibility for training and mentoring fellow colleagues, sharing best practices with the broader business community and responding directly to business questions.



+ Proactive stewardship of selected key change efforts across Submissions Management and peers.



+ Define, design and implement continuous improvement programs ensuring integration vertically and horizontally across relevant business lines and external providers, and alignment with business strategies.



+ Identify and define return on investment through business analysis of projects.



+ Analyze improvement programs and potential results.



+ Facilitate and may coach improvement teams.



+ Establish performance metrics to measure program success.



+ Install process excellence support for program governance, project reviews, communications and training.



+ Lead change management and communications relating to non drug projects; global, cross-regional and/or within region in line with priority business need.



+ Lead the development and maintenance of service level agreements with applicable business partners. **Compliance and Conformance Oversight**







+ Ensures the Translation and Dossier execution procedural documentation adheres to internal standards and policies allowing the business to be inspection or audit ready.



+ Drive consistency in global processes across hubs wherever possible.



+ Work with peers and contributors to ensure deviations/regional exceptions are reasonable and documentation as necessary.



+ Work with peers and contributors to ensure business change is documented and communicated in adherence to internal standards.



+ Act as audit readiness and process documentation subject matter expert across Submissions Management, providing direction and leadership for appropriate actions to ensure audit readiness and appropriate adherence to document change management including communication expertise and refinement.



+ Drives changes in policies and strategies to meet evolving business needs and maintain inspection readiness.







**Technical Skill Requirements**







+ Demonstrated ability to lead, influence and operate seamlessly across the organization ensuring timely and quality delivery of projects that meet evolving business needs, demonstrating attention to detail.



+ Demonstrated ability to understand and conduct data analytics, trending and result delivery, inclusive of issue resolutions.



+ Ability to communicate complex business information and analyses to a variety of audiences in both verbal and written format, across various cultures



+ Ability to meeting the expectations and requirements of key internal and external stakeholders, establishing and maintaining effective relationships, gaining trust and respect.



+ Ability to provide expert input to respond directly or indirectly to new business questions from key internal and external stakeholders.



+ Demonstrated business acumen; strong organizational management skills, the ability to manage multiple demands simultaneously; the ability to respond to tight timelines in a highly regulated environment



+ Proven ability to embrace new technologies and drive their implementation.



+ Demonstrated experience and proven success in project management.



+ Demonstrated experience and proven success in process design and development.



+ Proven experience to effectively handle multiple and diverse business support work assignments under pressure.



+ Proven experience delivering through others in a team environment



+ Ability to effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on.



+ Strong knowledge of the drug development process, regulatory affairs, and operations



+ In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.



+ Knowledge of relevant business systems, processes, information and technical tools and skills to translate and present visualization of data into a format that can trigger action and business decisions



+ Understanding of systems such as but not limited to document management systems, milestone reporting tools, and other electronic technologies to be used in support of Data management & research



+ Promotes peer relationships -can quickly find common ground and solve problems for the good of all; easily gains trust and support of peers; encourages collaboration.



+ Demonstrated good interpersonal, communication, negotiation, influencing, and problem-solving capabilities.



+ Demonstrated ability to identify issues, obstacles, and opportunities.



+ Demonstrated ability to effectively lead, influence and operate seamlessly across the organization ensuring timely and quality delivery of multiple high complex projects that meet evolving business needs, demonstrating attention to detail.



+ Demonstrated experience and proven success in project implementation.



+ Ability to use a range of effective communication styles and creates an inclusive environment with internal/external stakeholders to deliver goals and promote quality.



+ Uses diplomacy and tact and can diffuse high-tension situations comfortably.



+ Ability to provides expert input to respond directly or indirectly to questions and challenges from Submissions Management, WSR and WRD leadership and key internal and external stakeholders.



+ Ability to extract customer information and uses it for improvements in products and services.



+ Demonstrated ability to design and implement KPIs and complete complex data analysis.



+ Demonstrated ability to lead and direct resources through matrix or vendor management.



+ Demonstrated business acumen; proven organizational management skills, and ability to manage multiple demands simultaneously; ability to respond to tight timelines in a highly regulated environment



+ Ability to partner with Senior leaders in support of organizational objectives through strategic business planning



+ Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances



+ Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines



+ Ability to effectively handle multiple and diverse business support work assignments under pressure.



+ Proven accountability and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.



+ Demonstrated leadership and flexibility in dealing with change and diversity as part of a global team.



+ Demonstrated ability to identify issues, obstacles, and opportunities and then develop and implement effective solutions in partnership with applicable key stakeholders. **Qualifications (i.e., preferred education, experience, attributes)** **Education**







+ B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered **Experience:**







+ Experience in ability to function autonomously at senior levels and in a matrix team environment.



+ Experience in data analytics, generation, and interpretation.



+ Experience in a project / change management



+ Experience in multiple and diverse business support work assignments under pressure



+ Experience working in a challenging customer service environment







Day (standard) (United Kingdom)



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