Director, Clinical Trial and Data Transparency

This is a fully remote position, open to applicants in India.

📋 Description

• Provide expertise in the subject matter to assist teams in formulating global strategies for the disclosure of clinical documents in line with applicable regulatory standards.

• Oversee the planning and preparation activities for disclosures.

• Ensure high-quality information, consistency across disclosures and related areas (such as publications and data sharing), and timely completion of disclosures.

• Supervise vendors assigned to disclosure-related deliverables.

• Anticipate and monitor outsourced disclosure deliverables.

• Serve as the main point of contact for vendors at Pfizer, develop performance metrics, and engage in governance meetings.

• Foster open communication concerning project status and issue resolution.

• Spearhead the creation of standardized processes and/or the implementation of technological solutions to ensure compliance with disclosure mandates.

• Represent Medical Writing on committees governing clinical trial disclosures.

• Enhance the development of core expertise in disclosure and related fields within the Medical Writing team by staying informed on regulatory guidelines, requirements, industry trends, and best practices.

⛳️ Requirements

• A minimum of a Bachelor's degree or equivalent in a medical-related field or life sciences is required; a post-graduate degree is preferred.

• BS/BA with extensive experience, MS/MA with significant experience, or PhD with substantial relevant experience in the pharmaceutical or biotech sectors.

• Required experience in regulatory medical writing and preparing EMA Policy 70 submissions.

• Strongly preferred knowledge of data and/or document anonymization.

• Exceptional project management abilities to organize tasks and manage multiple projects simultaneously.

• Outstanding interpersonal, communication, and negotiation skills for effective collaboration with teams.

• Proven capability to establish and maintain professional and productive working relationships.

• Ability to leverage relevant knowledge and experience to address complex challenges, demonstrating flexibility and persistence when necessary.

🏝️ Benefits

• Remote Work Location Assignment: Remote

• Pfizer is an equal opportunity employer and adheres to all applicable equal employment opportunity legislation in each jurisdiction where it operates.