Clinical Trial Transparency and Disclosure Manager (Sr. Manager)

ROLE SUMMARY

The Clinical Trial Transparency and Disclosure Manager (Senior Manager/Associate Director) is an integral member of the Medical Writing department. The role is responsible for preparing clinical regulatory documents pertaining to Pfizer-sponsored interventional trials for disclosure 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 demonstrate advanced knowledge of relevant regulatory requirements and technical understanding of business processes in order to work with and lead project teams and vendors and to drive the development of high-quality and compliant disclosures.

ROLE RESPONSIBILITIES

• Prepares clinical regulatory documents for public disclosure by applying knowledge of relevant 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.
• Provides project teams with guidance for identifying applicable disclosures and preparing disclosures to comply with regulatory requirements and company policies/SOPs. Collaborates with project teams to ensure quality of information in disclosures, consistency across disclosures for multiple countries/regions, and timely completion of disclosures.
• Directs the work of vendors assigned to disclosure deliverables. Plans and manages timelines to ensure that vendors complete deliverables within agreed-upon timelines. Communicates work standards to vendors and reviews deliverables for quality. Identifies, communicates, and resolves issues affecting quality or timeliness.
• Communicates Medical Writing's position on resource and timeline needs for assigned disclosures to project teams, negotiating as needed with the team on these matters and keeping line management informed. Alerts project teams and line management of anticipated delays, information gaps, or potential quality issues.
• Stays abreast of evolving regulatory requirements and industry trends. Proactively fosters awareness of disclosure landscape within project teams.
• Identifies potential areas for process improvement and possible solutions and communicates these to line management or appropriate functional line.

BASIC QUALIFICATIONS

• Bachelor degree or equivalent in medical-related field or life science.
• BS/BA +8 years or MS/MA +5 years of relevant experience in the pharmaceutical or biotech industry.
• Experience with preparation of regulatory disclosures.
• 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.

OTHER INFORMATION

Eligible for Employee Referral Bonus: YES

PHYSICAL/MENTAL REQUIREMENTS

• Position located at GPD site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, participating in global conference calls that accommodate time zones.
• Ability to professionally communicate both verbally and in writing in English. Can discuss clinical data succinctly and accurately with cross-functional lines, scientific staff from a range of disciplines, and all levels of management

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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