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Director/Team Lead Compassionate/Pre


New York, NY
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Job Details

The Compassionate /Pre-Approval Access Director/Team Lead will represent Pfizer's commitment, internally and externally, to pre-approval access for patients to Pfizer investigational products. This role is responsible for a team of eight Compassionate Access Request Managers (CARMs) and oversees the global PfizerCAReS portal for all inquiries and requests of pre-approval products, approximately 2000 requests per year globally from treating physicians. This role and team works collaboratively with Clinical Development and Supply colleagues for oversight of the request process and fulfilment. Provides strategic leadership to shape Pfizer's policy, interpreting short and long-term requirements and defining the operational aspects to fulfill compliance needs. Works cross-functionally to ensure implementation of the PfizerCAReS program and the global policy/SOP CT16 Investigational/Unlicensed Product Use Outside of a Clinical Trial. This role report to the VP of Medical Affairs Platform Strategy

Responsibilities include but are not limited to the following:

+ Oversee the operational execution of the PfizerCAReS portal in accordance with CT-16 GSOP and CT16 POL.

+ Manage all related processes and resources performing day-to-day operational activities.

+ Oversee a team of Compassionate Access Request Members (CARMs)

+ Act as subject matter expert on Compassionate/Pre-Approval Access and represent on various teams and taskforces established.

+ Participate in appropriate governance and policy groups internally and externally. Empowered to make independent decisions affecting the operations of the group.

+ Provide knowledge and expertise on external environment pressures and evolving requirements to ensure Pfizer continues to meet compliance objective and continues to develop policies and standards in accordance with new/different mandates.

+ Collaborate with Global Medical, BT/Dev, DevOps to develop strategies that support business processes through utilization of Pfizer's key systems (e.g. Rightrack II, CAL, etc.)

+ Translate regulatory requirements (FDA, EMEA, and country specific) as well as Industry/PhRMA guidelines into standards and processes that allow Pfizer efficiency and effectiveness in meeting compliance.

+ Act as point of contact for all internal audits, and external inspections that include compassionate/pre-approval access.

+ Design, implement, and report out relevant compassionate/pre-approval access metrics

+ Leverage synergies with other groups and/or systems to increase efficiency.

+ Work closely with Medical, Regulatory, Safety, Legal, PCOs, and others to ensure needs are fully represented and integrated with each request and process based on internal guidelines

+ Serves as BPO of relevant POLs and SOPs and other operational processes needed for the successful execution of the compassionate/pre-approval access requests.

+ Ensure that appropriate operational standards and processes are implemented globally

+ Partner with internal functions to develop appropriate communication materials and correspond both internally and externally with key stakeholders regarding program


+ Advanced degree in Scientific/health care field required; doctoral level degree preferred

+ Experience (15+ years) working in biopharmaceuticals required

+ Experience with expanded access programs; management of overall programs a plus

+ Broad understanding of the external environment including regulatory, industry and patient issues related to compassionate/pre-approval access.

+ Broad understanding of clinical, safety and regulatory requirements and awareness of principles to support these functions and processes.

+ Solid knowledge of GCP and regulatory requirements along with a general understanding of the drug development process

+ Ability to lead diverse, cross-functional, virtual matrix teams, including contractors. Energizing and motivational capabilities, strong team player/coach.

+ Proven experience in effective communications across broad groups internally and externally and to senior management

+ Demonstrated ability to handle multiple tasks simultaneously, respond to tight timelines, and meet frequent and changing priorities

+ Independent, self-motivated with strong analytical and business skills

+ Problem solving skills, strong influence skills and demonstrated success to work with complex concepts/projects in a highly matrixed environment

+ Collaboration, interpersonal, and facilitation skills

+ Proficiency on relevant Pfizer tools (e.g., PfizerCAReS, etc.)

+ Communicates with impact and empathy

**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.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: April 5, 2018**

+ Additional Location Information: New York, NY; Collegeville, PA; Peapack, NJ; Groton, CT.

+ Eligible for Employee Referral Bonus

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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