Director, Clinical Trial and Data Transparency

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💰 Post-IPO Debt on 2023-05

We’re celebrating 175 years of daring scientific innovation—and we’re not done yet. Every day, we’re channeling our passion and resources into delivering innovative therapies that change the face of healthcare. Let’s outdo yesterday.

📋 Description

• Provide subject matter expertise to teams to develop global strategies for the disclosure of clinical documents in accordance with applicable regulatory requirements. • 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.