Epidemiology Research Assistant

ROLE SUMMARY

Pfizer's Global Medical Epidemiology (GME) group conducts observational epidemiologic research, often using large healthcare databases, to generate a better understanding of disease context and medical outcomes to improve medical decision-making for Pfizer medicines development. The three pillars of GME's remit are: (i) Regulatory Use of Epidemiology Data, (ii) Disease Natural History Studies to inform Clinical Trial Design, and (iii) Epidemiology Data for Quantitative Benefit-Risk Assessment. GME's impacts include improving the efficiency and likelihood of success of early phase clinical trials, building more robust benefit-risk profiles to provide a more thorough assessment of new products, and generating pivotal epidemiologic evidence to support regulatory filings. GME's value is based on deeper understanding of disease that improves quality and precision of Pfizer medical decisions.

The mission of GME is to employ the scientific methods and principles of epidemiology to secure regulatory approval, accelerate clinical development, and build benefit-risk profiles. We are looking for an Epidemiology Research Assistant to join GME and contribute to our mission of understanding diseases across all stages of drug development, which accelerates the availability of breakthrough medicines that impact patients' lives. This role will report directly to the Vice President, Global Medical Epidemiology, based in Collegeville, PA and would work across therapeutic areas to support Epidemiology Strategic leads and Epidemiology Scientists.

ROLE RESPONSIBILITIES

Literature Reviews

• Conduct literature reviews and other background research needed for various regulatory documents and regulatory requests including:
  • Epidemiology sections of Risk Management Plans (RMP)
  • Pediatric Study Plans, Pediatric Investigational Plans (PIP)
  • Orphan Drug Applications
  • Ad-hoc regulatory requests

• Critically assess, synthesize and summarize bodies of scientific literature across multiple disease areas, study designs, and populations.
• Maintain version control of documents and facilitate multiple rounds of review and revision.
• Ensure completion of quality control (QC) requirements for literature reviews and other background research deliverables.
• As needed, conduct quantitative analyses of public use and private data sources (e.g. SEER, NHANES, Kantar NHWS, Optum via IHD).
• Develop presentation materials that effectively communicate literature review findings to internal audiences.
• As needed, present literature review findings to internal audiences.
• Develop processes for automation of literature searches, archival of written summaries, and tracking of work volume.
• As needed, manage submission of literature review requests to external vendors, and direct their completion.
• Participate in enterprise-level initiatives related to literature reviews (i.e. CTDI Epi Library).

Research Support

• Provide research support to GME Strategic Leads and Epidemiology Scientists for the design, conduct, and analysis of GME studies and projects, such as:
  • Natural history of disease studies.
  • Comparative Cohorts.
  • Post-approval safety studies and their feasibility assessments.
  • Descriptive Epidemiology Studies for Pfizer's Clinical Trials Diversity Initiative.

• Support research to identify diagnosis and procedure codes used for studies using real-world data.
• Assist with preparation of regulatory documents, manuscripts, and other written reports.
• Works under supervision of GME Strategic Leads and Epidemiology Scientists.
• Work collaboratively with GME colleagues and as needed, key stakeholders internally and externally.
• Develop and refine processes to perform research support and literature reviews more efficiently.

BASIC QUALIFICATIONS

• Master of Public Health (MPH), Master of Science (MS) in epidemiology or a related discipline.
• At least two years' experience working in a research setting in academia or a public health organization.
• Excellent organizational and writing skills
• Proficiency with Microsoft Office suite.
• Familiarity with online medical literature search engines (e.g. PubMed, EMBASE, OVID, TDR's Incidence Prevalence Database).
• Ability to critically appraise medical literature and synthesize a large numbers of studies.
• Proficient at producing tables, figures, and slides.
• Can manage more than one project simultaneously, prioritizing well and recognizing key issues
• Interpersonal skills to seamlessly interact on both business and scientific issues.
• Excellent collaborator who can build working relationships with a diverse group of colleagues.
• Creative problem-solving skills in designing alternative approaches, new solutions, or innovations
• Ability to identify common operational trends and to standardize and optimize processes for ease of implementation.

PREFERRED QUALIFICATIONS

• One to three years' experience in the pharmaceutical industry or related organizations, and/or interacting R&D and/or commercial organizations in the pharmaceutical industry.
• Demonstrated ability to conduct high-quality comprehensive literature reviews in the pharmaceutical industry, academia, and/or regulatory agencies
• Experience writing epidemiological sections of scientific documents such as research summaries, publications, grant proposals, risk management plans, etc.

Other Job Details:

Last Date to Apply for Job: May 3rd, 2021

Additional Location Information: New York, NY; Collegeville, PA; US - Remote

#LI-PFE

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.

Medical