Pfizer Director, Reference Safety Information Team Lead in New York City, New York
This position has direct staff management of colleagues responsible for the creation and maintenance of Investigator Brochures (IB.) This role serves as the Business Process Owner, ensuring that efficient and quality processes are in place for a.) The execution and maintenance of Investigator Brochures and b.) Management and oversight of non-IB reference safety information (RSI) documents.
This position will also ensure the appropriate management, communication, and oversight of clinical trial reference safety information documents and guide colleagues involved with the triaging and coordination of reference safety information across the enterprise.
This role serves as a company subject matter expert for Investigator Brochures and other applicable reference safety information regulatory requirements. This role interprets regulatory requirements and guidances considering a wide range of internal stakeholder, e.g. Safety, Regulatory, Asset Team, etc. needs. This role collaborates within GPD and WRD functions to drive RSI strategy by guiding and advising teams on internal policies/procedures and external requirements; forging alignment and consistency across the Pfizer portfolio.
In addition, this position may have individual responsibility for the creation and maintenance of Investigator Brochures for a small number of products.
Provide management, leadership and mentorship to team of direct reports. Establish team objectives and work assignment distribution.
Oversee the execution of all company Investigator Brochures - ensuring optimal preparation, submission and communication.
As needed, lead/drive IB discussions with cross-functional asset teams setting expectations and key timelines. Oversee development of IBs from nonclinical to post marketed products - driving the IB strategy, providing visibility and guidance on the 1-2 year plan for the IB.
In accordance with applicable regulatory guidance, and in collaboration with other key roles, establish strategic direction of Single Reference Safety Document (SRSD) identification, triage, tracking and company dissemination. Ensure efficient flow and coordination activities of Single Reference Safety Document (SRSD) management across the enterprise. Assess and mitigate risks to ensure quality control and appropriate oversight.
Lead complex RSI-related improvement or technology initiatives that aim to simplify, automate and add value/quality to the overall SRSD process.
Interpret external regulatory requirements and perform impact assessments. Propose method for practical implementation of new emerging guidance/regulations and lead efforts to introduce changes to the organization.
Act as SME and point of contact for all inspections and audits. Represent Pfizer in various industry groups (for example, DIA Labelnet, industry working groups).
Good understanding of industry and comprehensive knowledge of drug development process. Experience with regulatory and safety guidelines and understanding of medical terminology.
Understands external regulations and ability to assess implications of regulations and mitigate/proactively plan for changes necessary. Demonstrated ability to influence and negotiate despite having a wide and diverse set of stakeholders.
Proven leadership in leading global teams through consistent execution and delivery. Demonstrated ability to foster strong matrix team working relationships.
Solid project management with a strong focus on quality and compliance.
Demonstrated ability to lead complex initiatives across stakeholders and implement effective change.
Proven effective written and oral communication. Demonstrated ability to juggle multiple priorities.
Leading initiatives and guiding direct reports to manage day to day work as well as process/technology improvements.
Change agile and comfortable in situations with ambiguity. Ability to help others through change curve and detail uncertainty.
BS in Life Science or equivalent degree required. Advanced degree highly desirable.
Experience and Attributes:
10 years plus experience of pharmaceutical experience, preferably within Regulatory and/or Clinical.
Proven successful experience leading and mentoring team of direct reports as well as leading/influencing matrixed cross functional team.
Experience with business process ownership and designing efficient robust/quality processes required.
Experience with reviewing, interpreting, planning for and executing to meet external regulations.
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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.
Other Job Details
Additional sites - Groton, CT, Peapack, NJ, Collegeville, PA, Sandwich UK, Walton Oaks UK
Eligible for Relocation Package: yes
Eligible for Employee Referral Bonus: yes
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.