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Merck · 1 month ago

Associate Director. Technical Project Management

USA - New Jersey - Rahway

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$140K/yr - $220K/yr

6+ years exp

Merck is a leading pharmaceutical company focused on digital solutions in chemistry, manufacturing, and controls. The Associate Director of Technical Project Management will oversee the roadmap definition, development, and delivery execution of digital solutions that enhance regulatory authoring processes, ensuring effective data management and governance.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Roadmap Definition and Ownership: Working with Digital CMC and business stakeholders, the business owner will identify the sections, plan discovery activities with the business areas, and project deliverables into a roadmap spanning clinical, first market, and post approval submissions across the pipeline. The applicant will be responsible for maintaining this roadmap in response to shifting priorities and an evolving pipeline

Development and Delivery Execution: The analyst will direct the efforts of a cross-functional development and delivery team to meet the business requirements. They will maintain the project backlog and continuously populate future sprints with execution ready tasks

Business Adoption: The applicant will oversee user testing by business representatives and drive continuous improvement through the definition and monitoring of KPIs and performance metrics. They will identify change agents within the business and educate them in the use of the application and how to enroll additional users

Creation of Reusable Data: The applicant will identify key data fields for contextualization within data products in support of regulatory filings for top pipeline programs. Additional use cases will be considered and prioritized appropriately to drive the adoption of data centric processes across the CMC continuum

Establish Standards and Governance: The applicant will set standards for structured content, data models, and governance that support scalable and compliant authoring in a sustainable way. Recommendations for data hygiene are to be developed and incorporated into the application and digitally enabled workflows

Qualification

Regulatory AuthoringData GovernanceDigital TransformationData ModelingProject ManagementManufacturing ProcessesStakeholder Relationship ManagementTechnical ManagementTechnology TransferCommunicationTeam LeadershipProblem-SolvingOrganizational Skills

Required

Knowledge of manufacturing, testing, quality, and supply chain processes from late clinical development through commercialization, with practical insight into how these operations generate CMC regulatory content

Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation

Hands-on experience in regulatory authoring and submission documentation, including preparing, reviewing or supporting filing ready content and structured filing outputs

Proven ability to deliver results in a complex environment with shifting priorities and multiple stakeholders

Experience in digitization and data management initiatives in regulated environments, including creation of re-usable data products, data modeling, and data governance

Working knowledge of key enterprise systems (LIMS, MES, SAP) and practical experience coordinating their integration into data pipelines, APIs or ETL processes for downstream authoring use

Skilled in creating and managing detailed cross-functional project plans and driving execution with accountability

Strong team contributor, promoting an inclusive and collaborative environment

Effective problem-solving, conflict resolution, and ownership-driving skills

Excellent verbal and written communication, with the ability to tailor messages to the audience and actively listen

Highly organized, able to prioritize tasks to ensure project success

Demonstrated project management skills, including leading cross-functional workshops, gathering and prioritizing requirements, and defining and tracking KPIs

Preferred

Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document assembly) from source systems

Background in analytical development or commercialization, with knowledge of method development, validation, specification setting and justification

Practical knowledge of content models/structured content, metadata, and data template design to enable automated authoring

Experience with data integration patterns and tools (APIs, data pipelines) and relevant systems (LIMS, MES, SAP)

Experience in data governance, data stewardship, and data quality management in regulated environments