Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Executes global CMC regulatory strategies for post-approval pharmaceutical changes, including product change assessments, health authority responses, regulatory submissions, dossier updates, and technical justifications. Coordinates cross-functional reviews, document sign-off, query and commitment management, risk escalation, and regulatory system maintenance. The role requires applying international regulatory guidelines and managing multiple projects under team-lead guidance.
Top Skills:
DatabasesDocument Management SystemsGdmsWindowsNavigationPdmPublishing ToolsSpaSubmission Management ToolsTrackwise
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports global pharmaceutical regulatory CMC activities for license renewals and annual reports. Authors and compiles CMC dossier contributions, reviews post-approval changes and stability information, applies regulatory guidelines, develops technical justifications, coordinates document reviews, manages commitments and queries, and updates submission components. Collaborates with global regulatory strategists, manufacturing, supply, and cross-functional teams while monitoring timelines, risks, compliance, and submission accuracy.
Top Skills:
GdmsPdmPearlSpa
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports CMC regulatory activities for pharmaceutical license renewals and annual reports across global markets. Responsibilities include authoring and compiling regulatory dossier contributions, reviewing technical and stability information, applying U.S. regulatory guidelines, coordinating document reviews and approvals, updating dossier components, managing timelines and risks, and using Pfizer regulatory systems. Requires postgraduate education in Pharmacy or Science and foundational knowledge of post-approval regulatory requirements.
Top Skills:
GdmsPdmPearlSpa
ROLE SUMMARY
In Pfizer Digital Research & Development, we work with our R&D partners to accelerate drug development and clinical trials through digital products and solutions.
Within Digital R&D, the Veeva Platform & Services function is responsible for defining the strategy and leading the delivery of the Veeva product suite to end users of Veeva products within Digital R&D. This includes the operation, implementation, and integration of Veeva platform solutions that address R&D business processes effectively. Veeva solutions include Regulatory - RIM (Registrations, Submissions, and Publishing), Clinical (CTMS, eTMF, Study Start Up, and Site Connect), and Quality (QMS and Quality Docs).
Your role as a Veeva Run Operations Associate involves contributing to the delivery of seamless operational support, system implementation, and system maintenance activities to support the ongoing operations of implementing the Veeva Platform across Pfizer's global business units. The Veeva Run Operations team is expected to develop, implement, and manage the technical support framework to provide timely, high-quality, value-added services to enhance user productivity.
ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Information & Business Tech
In Pfizer Digital Research & Development, we work with our R&D partners to accelerate drug development and clinical trials through digital products and solutions.
Within Digital R&D, the Veeva Platform & Services function is responsible for defining the strategy and leading the delivery of the Veeva product suite to end users of Veeva products within Digital R&D. This includes the operation, implementation, and integration of Veeva platform solutions that address R&D business processes effectively. Veeva solutions include Regulatory - RIM (Registrations, Submissions, and Publishing), Clinical (CTMS, eTMF, Study Start Up, and Site Connect), and Quality (QMS and Quality Docs).
Your role as a Veeva Run Operations Associate involves contributing to the delivery of seamless operational support, system implementation, and system maintenance activities to support the ongoing operations of implementing the Veeva Platform across Pfizer's global business units. The Veeva Run Operations team is expected to develop, implement, and manage the technical support framework to provide timely, high-quality, value-added services to enhance user productivity.
ROLE RESPONSIBILITIES
- Apply fundamental knowledge of technology principles, concepts, and theories to drive improvements in the implementation and operation of the Veeva platform.
- Manage day-to-day system activities, including business support & incident management by using knowledge of internal/external business challenges and established guidance.
- Resolve system development and/or maintenance activity issues and risks, escalating them as needed.
- Develop, test, and implement Veeva system enhancements
- Partner closely with business teams to implement changes, manage project plans, and drive operational improvements in our production systems.
- Learn and apply industry knowledge and build understanding of business processes to deliver robust technology support for Veeva systems.
- Leverage existing information and contribute to stakeholder engagement and communication.
- Participate in knowledge-sharing activities with others within team through existing knowledge sharing processes/systems.
BASIC QUALIFICATIONS
- HS Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelor's degree with 0+ years of experience in Computer Science, Software Engineering, or a related technical field.
- Service delivery experience, preferably in pharmaceutical industry
- Technical support and operations management experience participating in robust, cost-effective, high-quality services for external and internal customers.
- Participating in cross-functionals teams including business subject matter experts, technical experts and compliance teams for project execution.
- Good knowledge of analytics, quantitative and problem-solving skills to drive decisions for optimized solutioning.
- Knowledge of stakeholder management, facilitation, influencing and negotiation skills.
- Strong working knowledge on MS Tools - Project, Word, PowerPoint, Excel.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Information & Business Tech
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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