Pfizer

Dir, Clinical Trial and Data Transparency

Posted Yesterday

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2 Locations

Remote or Hybrid

Expert/Leader

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Lead clinical trial disclosure strategy and operations for Pfizer-sponsored interventional trials. Ensure timely, compliant posting of protocols, SAPs, CSRs, and clinical summaries per EMA Policy 70 and other regulations. Manage vendors, develop processes and technical solutions, represent Medical Writing on governance committees, and maintain regulatory knowledge and best practices to drive quality and consistency across disclosures.

Summary Generated by Built In

Role Summary
The Clinical Trial Transparency and Disclosure Lead is an integral member of the Medical Writing department. The role is responsible for providing strategic and operational expertise to support the disclosure of clinical regulatory documents pertaining to Pfizer-sponsored interventional trials on public websites. Disclosures include, but are not limited to, protocols, statistical analysis plans, clinical study reports, and clinical summaries/overviews from marketing applications. This role must be facile in innovative problem solving, influencing peers, and change management.
Role Responsibilities

Provide subject matter expertise to teams to develop global strategies for the disclosure of clinical documents in accordance with applicable regulatory requirements. These requirements include, but are not limited to, EMA Policy 70, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information Guidance, and pertinent company policies/SOPs.
Manage planning and preparation activities for disclosures. Drive quality in information, consistency across disclosures and related areas (eg, publications and data sharing), and completion of disclosures in a timely manner.
Oversee vendors assigned to disclosure deliverables. Forecast and track outsourced disclosure deliverables. Act as the Pfizer point of contact to vendors, develop performance metrics, and participate in governance meetings. Promote open communication regarding project status and issue resolution.
Lead development of standard processes and/or implementation of technologic solutions to enable compliance with disclosure requirements.
Represent Medical Writing on clinical trial disclosure governance committees. Contribute to development of core expertise in disclosure and related fields within Medical Writing group by maintaining knowledge of regulatory guidelines and requirements as well as industry trends and best practices.

Basic Qualifications

At minimum Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
BS/BA with extensive experience, MS/MA with strong experience, PhD with strong relevant experience in the pharmaceutical or biotech industry.
Experience with regulatory medical writing and preparation of EMA Policy 70 submissions required. Knowledge of data and/or document anonymization strongly preferred.
Excellent project management skills to organize work and handle multiple projects at the same time.
Excellent interpersonal, communication, and negotiation skills to effectively work with teams. Proven ability to establish and maintain professional and productive working relationships.
Ability to apply relevant knowledge and experience to solve complex problems, using flexibility and persistence as appropriate.

Preferred Qualifications

Advanced degree (MS/MA) is preferred.
Knowledge of data and/or document anonymization strongly preferred.

Non-Standard Work Schedule, Travel or Environment Requirements

Some travel (~5%) across GPD sites for face to face meetings, if necessary. Depending on location may need to accommodate global teleconference calls across different time zones.

Work Location Assignment: Remote
Work Location Assignment: Remote
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical

Skills Required

Bachelor's degree in a medical-related field or life science (or equivalent)
Experience in the pharmaceutical or biotech industry (BS/BA with extensive experience; MS/MA or PhD with strong relevant experience)
Experience with regulatory medical writing and preparation of EMA Policy 70 submissions
Excellent project management skills, including organizing and handling multiple projects simultaneously
Excellent interpersonal, communication, and negotiation skills
Ability to apply knowledge to solve complex problems, with flexibility and persistence
Advanced degree (MS/MA or PhD)
Knowledge of data and/or document anonymization

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Health coverage includes comprehensive medical with robust mental‑health networks, plus dental and vision options, and coverage for infertility/family‑building and transgender‑affirming care. Recent U.S. summaries name mental‑health partners and outline multiple plan choices.
Retirement Support — The retirement program provides a 401(k) with company match plus an additional employer Retirement Savings Contribution, along with financial‑planning support and company‑paid life and disability insurance. These elements are highlighted as part of the core U.S. package.
Parental & Family Support — Parental leave is described as up to 26 weeks in the U.S. when combining paid non‑medical parental leave with medical recovery where applicable, with exact pay and weeks dependent on circumstances and plan elections. Family‑building support includes egg preservation, adoption, and surrogacy coverage.

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.