PFIZER LIMITED

Sr. Team Manager, CDM Shared Services Cluster

Sr. Team Manager, CDM Shared Services Cluster
Job Location:  Chennai
Job Description:  SkillSet: sla, customer relations, coaching, customer service, sales.

Job Summary

Reporting to global head, centralized data management with direct and matrix management people responsibilities - to manage Pfizer s centralized data management activities within the GPD Global Product Development Global Regulatory Operation (GRO) group. Ensures the integrity and Quality of Pfizer regulatory intelligence, by the tracking of regulatory milestones and maintains compliance with applicable regulatory obligations whilst working to tight business-critical timelines within a highly regulated environment.

Responsible for the development, leadership and performance management of the SCC team to achieve the regional cluster or shared services goals in terms of regulatory systems updating in compliance with the best accuracy and quality standards, based on the regulatory data provided by the different countries and following the applicable policies, SOPs and working instructions (WI).

Job Responsibilities

Key Accountabilities:

  • Regionally focused data management oversight workload management.
  • Manage data associates and interface with functionally responsible roles.
  • Ensure escalations, business process solution achieves business needs.
  • Contribute to evolving data management serve as a change agent within or across regions contact.
  • Liaise with regional BU strategists, and any other applicable partner lines at local (clinical, safety and medical area among others)
  • Coordinate the issuing of the reports and metrics as per need to evaluate team performance and data entry compliance.
  • Perform quality control of timeliness and accuracy data.
  • Develop key performance indicators in order to ensure accurate and timely execution of improvement initiatives and guarantee increased compliance in relevant processes.
  • Propose implement process enhancements as per BAU learnings.
  • Ensure team receives appropriate training materials and its correct implementation.
  • Coordinate with remote/local peers to ensure compliance with local and global regulatory requirements.
  • Develop and propose strategies to improve efficiencies and effectiveness while managing the data management activities.
  • Responsible to develop and enhance the capabilities and capacities of the SCC team throughout the identification and implementation of training and development needs.
  • Adhere to the appropriate use of technical tools, through use of working practices and qc/qa procedures such as regulatory and internal compliance.
  • Responsible for cluster team s professional development through coaching and motivation
  • Coach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities
  • Lead cluster data associate team using the performance management framework and development process that provides an overall context and framework to encourage employee contribution; includes goal setting, feedback, and performance development planning
  • Lead cluster data associate team to meet the organization s expectation s for productivity, quality and goal accomplishment
  • S/he will support other PPLS/Operations functions to meet growing business needs
  • Proactively works with global counterparts to address resource and process adjustments across sites and in support of business continuity
  • Leads or actively participates in cross functional teams to ensure lobal and global business deliverables are met in support of process improvement initiatives of the organization
  • Ability to autonomously influence business decisions where direct reporting line relationships do not exist.
  • Remains knowledgeable about current regulations and guidance s associated with Regulatory data
  • Makes recommendations for relevant department operating procedures. Responsible for creating and reviewing SOPs as needed.

Impact on the organization:

  • Efficient use of resources through operational effectiveness.
  • Improved accuracy and quality of global regulatory systems updates.
  • Reduce the Regulatory Strategist workload in terms of the updating data in Global Regulatory Systems.

Qualifications/Skills

  • Understanding of the concepts around regulatory activities.
  • Understanding of regional regulatory requirements.
  • Articulate with analytical and interpersonal skills.
  • Proven aptitude in project management and process redesign.
  • Demonstrated coordination of activities in a highly regulated environment.
  • Knowledge of the local regulatory environment and how this impacts regulatory strategy and implementation.
  • Knowledge of drug development practice, rules, regulations and guidelines.
  • Communication skills.
  • Negotiation skills.
  • Analysis and problem-solving skills.
  • Understanding stakeholder needs.
  • Customer service orientation.
  • Network and alliance building/ peer relationships.
  • Influencing skills.
  • Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner.
  • Interpersonal acumen.
  • Organizational agility.
  • Strong quality and compliance orientation.
  • Detailed oriented.
  • Analytical Thinking.
  • Adaptability.
  • English intermediate to advance (written and spoken)
  • Fluent in other languages dependent on cluster
  • Strong people management experience building efficient teams.
  • Strong Project Managements Skills: Mastery of processes, tools and techniques for planning and monitoring multiple complex processes and projects to established deadlines.
  • Ability to quickly understand, assess and adjust processes in support of quality, compliance and efficiency
  • Ability to streamline and manage a diverse set of processes across CDM globally.
  • General standards, processes and policies of Pharmaceutical manufacturing Industry
  • Sound interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities
  • An assertive, take-charge, proven manager with a strong results orientation, positive can do attitude, and a sense of urgency to get things done
  • Build, motivate and manage an effective team
  • English intermediate to advance (written and spoken)
  • Demonstrated experience in managing teams and people
  • Regulatory experience in regulatory activities
  • Master or undergraduate degree plus relevant experience in life science or business
  • Minimum of 5 years of relevant experience
  • Multi-lingual skills desirable
  • Project Leadership
  • Demonstration of experience working in a challenging customer service environment
  • Communication Skills: ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
  • Project Management skills: Mastery of processes, tools and techniques for planning and monitoring projects to established deadlines. Familiarity with pharmaceutical organizational structures, systems, and culture.
  • Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
  • Graduate in Pharmacy or Science.
  • 10 to 12 years of experience in Regulatory Affairs in a reputed Pharmaceutical Organization
  • Leading a group in the Regulatory Affairs/Regulatory Operations function in a reputed Pharmaceutical Organization with an experience of handling Regulatory Data as well as additional regulatory submission related activities

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

Regulatory Affairs,
Functional Area:  Sales / BD
Experience:  5 - 12 years
Qualification:  ("Other in Other")
Salary:  7 Lakh to 16 Lakh INR
 
PFIZER LIMITED
Job Ad publication date: 20 Nov 2020