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Thermo Fisher Scientific

Director, Digital Product Management - Medical Writing

Location
Remote (NC) · Remote
Posted
Posted yesterday (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Engineering/Technology
Industry
Pharma/Biotech
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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About the Role:

The Director of Digital Product Management for Medical Writing will lead the vision, strategy, and lifecycle of a global portfolio of AI-enabled products that help medical writers create high-quality, scientifically accurate, and compliant clinical documents. The portfolio includes a live informed-consent-form assistant and is expanding toward reusable capabilities across multiple medical-writing document types, including informed consent forms (ICFs), clinical study reports (CSRs), safety narratives, investigator's brochures, and clinical protocols.

This role is the senior product connection between Medical Writing and clinical development stakeholders, the PPD Digital Product Domain Head, technology teams, and delivery partners. It owns product outcomes from discovery and roadmap definition through delivery, adoption, production performance, and value realization. Success requires strong product judgment, deep customer empathy, and the ability to lead AI-enabled clinical products in regulated environments where human accountability, traceability, data protection, and quality are built into every release.

This is a remote role for qualified candidates in the US, Canada or Mexico.

Key Responsibilities

Product Strategy and Portfolio Leadership

  • Define and communicate the product vision, multi-year strategy, and outcome-based roadmap for the AI Medical Writing portfolio.
  • Translate Medical Writing and clinical development priorities into a coherent portfolio of reusable product capabilities rather than disconnected point solutions.
  • Act as the senior product partner to business leaders and the PPD Digital Product Domain Head, creating clarity on product outcomes, priorities, investment choices, dependencies, and trade-offs.
  • Build strong product-management practices and coach product owners and cross-functional contributors, establishing clear decision rights and accountability.

Product Discovery and Clinical Workflow

  • Develop a deep understanding of medical writers, reviewers, approvers, and operational users through direct discovery, workflow observation, user research, and Voice of Customer activities.
  • Define intended users, problems to solve, use cases, requirements, acceptance criteria, and measurable success outcomes for each capability and document workflow.
  • Ensure products support human-in-the-loop authoring and review, with appropriate source traceability, version lineage, scientific integrity, and final accountability retained by qualified users.
  • Represent the full content lifecycle, including authoring, review, amendment, approval, reuse, and downstream submission or archival needs.

Execution Delivery and Partner Leadership

  • Lead a global, matrixed delivery model spanning product, engineering, data science, user experience, quality and validation, information security, operations, and external vendors.
  • Own product scope, backlog priorities, release goals, acceptance criteria, definition of done, and product readiness decisions, balancing speed, quality, risk, and user value.
  • Set clear expectations for delivery partners and vendors; manage outcomes, quality, timelines, dependencies, escalations, and transparent communication with senior stakeholders.
  • Partner with technical leaders on build, buy, and partner choices and on architectures that support secure, scalable, maintainable, and reusable capabilities.

AI Product Quality and Regulated Use

  • Shape product requirements for generative AI and other automation approaches, working with engineering and data-science leaders to evaluate feasibility, limitations, performance, and operating risk.
  • Establish product-level quality measures and evaluation approaches for content accuracy, completeness, consistency, critical errors, reviewer effort, and appropriate use.
  • Embed responsible AI, privacy, security, validation, auditability, and regulatory expectations into product decisions in partnership with the relevant control functions.
  • Ensure release evidence demonstrates that each capability is fit for its intended use and that known limitations, fallbacks, and human review responsibilities are clear.

Lifecycle Adoption and Value

  • Own the full product lifecycle from opportunity discovery and business case through launch, production support, continuous improvement, and retirement or replacement decisions.
  • Define and monitor product measures covering adoption, user experience, document quality, cycle time, review effort, reliability, operational efficiency, and business value.
  • Lead launch readiness, stakeholder communications, training, change enablement, and feedback loops so capabilities are embedded in day-to-day Medical Writing practice
  • Use production insights, support themes, defects, and user feedback to continually refine priorities and improve product outcomes.

Market Customer and Commercial Insight

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