US Drug Shortage Lead Secondment - 6 months

Why Patients Need You
Drug Shortages in the United States pose serious challenges impacting patient safety disruption of medical care and significant impact on public health. Resolving drug shortages requires coordinated efforts across the Food and Drug Administration (FDA) manufacturers and healthcare providers to ensure a stable and reliable supply of essential medicines.

US Drug Shortage Lead is responsible for leading the development and of FDA communications pertaining to supply interruptions and stock out notifications for products covered within PFS (Pre Filled Syringes) PnP (Premixes Specialty Solutions Cardiovascular Fragmin Opioid Vials) NEWS (Neurology Endocrinology Women (Ob/Gyn) Steroids) AASC (ADDVantage Atgam SoluCortef) and PC1 Portfolios. Specifically the colleague in this role will ensure sound communication strategies and proactive reporting to the FDA Drug Shortage Staff (DSS).

What You Will Achieve
The US Drug Shortage Lead will oversee multiple Pfizer portfolios to execute appropriate FDA notifications and summary strategies following comprehensive review of supply outlook manufacturing delays and market dynamics. The colleague will develop and manage FDA communications working with and seeking input from crossfunctional team members including Pfizer Global Supply Regional Supply Service Center (RSSC) and Demand partners Commercial Marketing and Communications Legal Medical Regulatory and other teams as needed. The colleague will collaborate with strategy to develop proposals to mitigate supply gaps in cases where Pfizer is unable to address constraints internally. The colleague will be responsible for reviewing/submitting the FDA biweekly posting process SCC communication uploading monitoring supply of molecules within identified portfolios escalating areas of concern for essential products progressing product discontinuations new product and product presentation launches and product transfer activities.

US Drug Shortage Lead reports directly to the Director of US Drug Shortage and Business Operations Lead.

How You Will Achieve It

• Monitor and review products in SIQ within PFS PnP and AASC PC1 Portfolios

• Attend BiWeekly Supply Calls with Pfizer Global Supply Regional Supply Service Center (RSSC) Demand planners and Commercial Portfolio leads

• Collaborate with crossfunctional teams including Pfizer Global Supply RSSC Customer Service Customer Marketing and Communications Medical/Regulatory/Legal and Corporate Affairs to problem solve and align on supply mitigation strategies

• Attend Demand Supply Alignment (DSA) calls to discuss opportunities for prioritization site resource and manufacturing constraints

• Attend US SINJ Customer calls and Hospital Sales & Operating Plan (S&OP) calls reviewing demand supply product/network changes and financial plans across Hospital Quad/Triads

• Participate in SI Gx regulatory weekly calls to discuss key issues and opportunities for mitigation within SINJ portfolio

• Track and measure communications for monthly drug shortage metrics

• Prepare talking points and meeting materials for FDA standard forums

Qualifications

Must have

• Applicant must have a bachelors degree with at least 4 years ofexperience; OR a masters degree with at least 2 years of experience; ORa PhD with 0 years of experience; OR as associates degree with 8 yearsof experience; OR a high school diploma (or equivalent) and 10 years ofrelevant experience.

NiceToHave

• Regulatory experience Indepth understanding of United States regulatory legislation and guidelines

• Excellent written and oral communications skills.

• Proven track record of delivering effective and precise communications

• Strong writing and project management experience; track record of reliable and timely communication planning and .

• Proven ability to work effectively and inclusively in teams with diverse internal and external stakeholders; influence negotiation and stakeholder management skills.

• Strong knowledge of healthcare and biopharmaceuticals industries. Preferred knowledge of hospital generics / sterile injectables market

• Able to work to tight deadlines manage multiple projects at once and maintain professionalism under pressure.

• Proactive selfstarter and able to work independently

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 providers 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 EVerify employer. This position requires permanent work authorization in the United States.

Relocation assistance may be available based on business needs and/or eligibility.