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 or Canada.
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
- Monitor the external market, customer needs, emerging AI capabilities, competitors, and regulatory expectations to inform differentiation and product positioning.
- Develop clear value propositions and evidence-based business cases in partnership with finance, commercial, operational, and technology stakeholders.
- Represent the portfolio with senior internal and external audiences, translating complex clinical and technical topics into clear product choices and outcomes.
What Success Looks Like
Medical writers and reviewers adopt the products because they make priority workflows easier, faster, and more reliable without compromising scientific or regulatory quality.
The portfolio advances through a clear, outcome-led roadmap with timely decisions, transparent trade-offs, and dependable delivery across internal teams and vendors.
AI-enabled capabilities are evaluated and released against explicit intended-use and quality criteria, with traceability and human oversight designed in.
Capabilities scale across document types through shared components, governed content and evidence, and reusable product patterns.
Investment decisions are supported by credible measures of adoption, quality, efficiency, customer value, and operational impact.
Education and Experience
- Bachelor's degree in life sciences, technology, business, or a related discipline; an advanced degree is preferred.
- Previous progressive product-management experience, including senior leadership of complex digital products or portfolios that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years’ experience).
- Demonstrated ownership of the full product lifecycle, including discovery, strategy, roadmap, delivery, launch, adoption, performance management, and value realization.
- Experience in clinical research, drug development, Medical Writing, regulatory content, or another highly regulated life-sciences environment is strongly preferred.
- Experience delivering AI, machine-learning, analytics, or workflow-automation products; practical familiarity with generative AI is highly desirable.
- Experience leading global, cross-functional teams and third-party delivery partners in a matrixed organization.
- In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities
- Strong product leadership: able to move between strategic portfolio choices, detailed workflow decisions, delivery trade-offs, and executive communication.
- Working knowledge of clinical-document authoring and review, including the quality, traceability, confidentiality, and regulatory expectations associated with clinical content.
- AI fluency sufficient to collaborate effectively with technical teams and to make informed decisions about model quality, evaluation, limitations, governance, and user experience.
- Excellent stakeholder and vendor leadership, with the confidence to create alignment, challenge assumptions, resolve ambiguity, and make timely decisions.
- Strong customer orientation and discovery skills, with the ability to convert user needs into clear product requirements and scalable capabilities.
- Commercial and analytical acumen, including business cases, portfolio prioritization, product metrics, and evidence-based value tracking.
- Clear, persuasive written and verbal communication, including the ability to explain complex clinical, product, and technical topics to different audiences.
- Sound judgment, resilience, and a collaborative leadership style suited to global teams operating across multiple time zones.
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require as-needed travel (0-20%).
Location: Remote US or Canada. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
The annual salary range estimated for this position in North Carolina is $185,000- $215,000 USD. In Canada, our estimated range is $133,000 - $200,000 CAD. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.