Dir, Clinical Trial and Data Transparency

Job Description:

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.

Qualification & Experience

• 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.