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Manager Patient Centered Outcomes Assessment


Collegeville, PA 19426
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Job Details

The Patient-Centered Outcomes Assessment (PCOA) Manager is committed to representing patients and the people who care for and about them by providing Clinical Outcomes Assessment (COA) operational support across the Pfizer portfolio of Drug Development Programs. The PCOA Center of Excellence is positioned within Pfizer's Patient and Health Impact (PHI) Function.

The PCOA Manager collaborates with the PHI & PCOA Asset Leads to obtain licensing and permissions to use COA measures, to identify availability of language translations or make translation process recommendations, and to advise on the mode of administration of COA measures.

**About Pfizer Patient and Health Impact**

Patient and Health Impact (PHI) is a group within Pfizer that brings together experts in health economics and outcomes research, real-world data, patient-centered outcomes assessment, market access, pricing, strategy and contracting. This group is responsible for ensuring patients have affordable, timely access to medicines and vaccines that can help optimize their overall health by generating evidence of value and working with payers and governments around the world to create access. Recognizing challenges with healthcare sustainability and the evolution to value-based care, this group is also exploring innovative approaches and new partnerships to transform the way Pfizer brings medicines and vaccines to market. We recognize our responsibility to be part of the solution and aim to be a leader in the industry.

PHI offers colleagues a distinct opportunity to support evidence-generation and market access strategies across Pfizer's entire portfolio through all lifecycle stages - from early pipeline to marketed brands to loss of exclusivity and switch to over the counter. Colleagues in PHI have an unparalleled opportunity to grow and develop, while making a meaningful contribution to patient and population health around the world.


+ Generation of proposals and contract terms for access to COA instrument databases

+ Alignment of PCOA instrument licensing, translation and data collection activities with the Commercial goals of the program e.g. labelling, publication, etc.

+ Assessment and interpretation of relevant literature to support the use of COA measures for a particular context of use, including an ability to communicate evidence to internal stakeholders

+ Management of contracted research projects (budget negotiations, quality assurance of work conducted by vendors) related to instrument selection and/or modifications

+ Identify and provide Asset teams with administration materials (e.g. manuals, patient tip sheets, etc.) and COA instrument scoring manuals/recommendations

+ Provide teams with specific details on COA license for use which includes terms, cost, instructions, scoring, training materials and language availability

+ Project manage (produce agendas, minutes, reminders and appointments) for the PCOA Technical Advisory Committee monthly meetings and PCOA staff meetings

+ Ensure appropriate license agreements are in place for the use of COA's in each clinical trial or program

+ Research and identify measures and language needs for use in clinical trials which may include providing input needed for country feasibility assessment

+ Review and provide comments on development of case report forms for COA measures

+ Evaluate the language availability for COA measures and collaborate with the team to create requests for proposals from vendors for translations needs for clinical trials and research studies

+ Work within a cross-functional team environment supporting multiple teams and therapeutic areas

+ Engage with preferred vendors, and leverage negotiated global agreements where possible

+ Assist the teams in choosing the most appropriate vendor with regards to proposals that are submitted for each project according to cost, quality, and timelines. Responsible for managing the Pfizer interactions with the vendor to ensure timely and high quality completion of translations by the vendors

+ Communication & collaboration effectively both internally and externally to ensure that the COA data and deliverables are of value and align with overall program goals

+ Triage of concerns and proactively engages the appropriate colleagues/team members to ensure that their concerns are explored and respect is given to their professional expertise and experience

+ Identification, evaluation, retention and overseeing of a global network of COA instrument developers, databases, translators, technology providers and contract organizations to execute the COA evidence generation strategies of Asset teams

+ Maintaining awareness of new tools and data sources to ensure COA instrument selection represents current state of the science

+ Models One Pfizer behaviors and champions the PCOA department vision by influencing peers and PHI leadership

+ Travels for work to meet with internal customers, present at scientific venues and attend departmental meetings domestically and/or internationally (approximately 15% but may require more depending upon business need)

+ Other duties as assigned



MA Psychology, Epidemiology, Statistics, Public Health or related discipline with 3+ years of experience (minimum of 2 in patient-reported outcomes or clinical outcome assessment), or BA Psychology, Epidemiology, Statistics, Public Health or related discipline with 5+ years of experience (minimum of 3 in patient-reported outcomes or clinical outcome assessment).

**Skills and Competencies:**


+ Understanding of global drug development, outcomes research and COA instrument development and the methods addressed in the FDA PRO Guidance

+ Experience in COA instrument use for inclusion in clinical studies

+ Technical compentency in systematic reviews and qualitative research

+ Technical competency in use of ePRO/eCOA , linguistic validation and cultural adaptation of COAs

+ Excellent organizations skills and ability to problem solve

+ Ability to clearly communicate to a vast audience of customers and the ability to align cross-functionally.

+ Self motivated and able to work independently

+ Strong process/project management skills

+ Experience working in a project management capacity associated with drug development teams supporting the operational delivery of clinical trials

+ Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers


+ Experience in evaluating and developing COA instruments for inclusion in clinical studies that meet regulatory agency standards for label claims

+ Excellent analytical skills and ability to draw insights/derive viable strategic options that offer opportunities to align cross-functionally

+ Ability to translate analytic skill into strategic vision of relevance to internal and external stakeholders

+ Knowledge of the disease areas within the Therapeutic Area

+ Able to independently engage all levels of stakeholders in PHI and the RU & BU through strategic thinking, leading change, and building collaborative partnerships in a matrix environment

+ Demonstrated ability to manage multiple projects (multitask) involving complex processes, competing deadlines and rapidly shifting priorities


Approximately 15% (possibly more if there is a business need) travel required to meet with internal customers, present at scientific venues and attend departmental meetings.

**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: 2/26/18** 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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