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