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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Pharmacoepidemiology, including the design and analysis of epidemiological studies, and the ability to manage strategic relationships and cross-functional teams. Proven track record in regulatory compliance, risk management, and generating real-world evidence to support clinical development.
Highest-signal resume keywords
Pharmacoepidemiology Strategy DevelopmentEpidemiological Study Design and AnalysisRegulatory Compliance and FilingsCross-Functional Project LeadershipStrategic Relationship Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Epidemiological MethodsData AnalysisRisk Management PlansBenefit-Risk AnalysisReal-World Evidence GenerationClinical Development SupportDatabase QueryingLiterature ReviewProject ManagementStrategic Planning
Soft Skills
CollaborationCommunication SkillsConsensus BuildingResiliencyInitiative
Tools & Technologies
Electronic Patient-Level DatabasesClaims DatabasesEMR SystemsSurveysRegistries
Industry Keywords
BiotechPharmaDrug Development ProcessRegulatory AgencyPost-Marketing StudiesPASSPAESPMRDUSREMS
About the role
Key responsibilities & impact- Build productive external partnerships across key areas
- Support identification, execution, and management of strategic relationships with organizations and institutions
- Coordinate across matrixed teams to identify opportunities and streamline external partnership initiation and maintenance
- Build an internal external-partnership capability regarded highly by partners and leaders
- Partner with internal leaders working with external partners to ensure collaboration, continuity, and alignment
- Develop and implement pharmacoepidemiology strategy in a designated therapeutic area
- Lead cross-functional project teams and epidemiology activities, including regulatory agency-required studies
- Generate epidemiology data supporting clinical development, regulatory filings, and approvals
- Serve as an in-house epidemiology subject matter expert
- Generate real-world evidence and conduct post-marketing epidemiologic studies, including PASS, PAES, PMR, DUS, and effectiveness of REMS and RMMs
- Contribute to Risk Management Plans, benefit-risk analyses, signal management, regulatory agency responses, and regulatory filings
- Provide epidemiological and risk-management strategy and support to project and product teams
- Design, implement, and analyze epidemiological studies
- Review study proposals from internal and external sources
- Explore external electronic patient-level databases, including claims, EMR, surveys, and registries
- Represent Pharmacoepidemiology on safety monitoring teams, clinical study teams, safety oversight committees, and independent data monitoring committees
- Lead non-compound-specific activities such as literature reviews and database queries
- Develop and maintain relevant SOPs and Working Instructions
- Drive process improvement activities and strategic initiatives
- Manage contractors and external vendors
- Develop and maintain professional relationships with external experts and opinion leaders
Requirements
What you’ll need- Minimum of a Bachelor’s degree
- 8+ years of relevant industry-related experience in Biotech/Pharma
- Qualifications commensurate with the Director level
- Knowledge of the latest epidemiologic methods and resources
- Previous experience in and deep understanding of the drug development process
- Ability to manage and prioritize multiple tasks and projects with a sense of urgency in a matrix organization
- Experience in planning and execution, with strategic thinking and tactical execution
- Strong business and financial management acumen
- Proven ability to build consensus with leaders and colleagues
- Proven track record of developing and maintaining relationships with partners at all organizational levels
- Results-oriented, collaborative style
- Demonstrated resiliency, initiative, and good judgment
- Outstanding verbal and written communication and presentation skills
- Ability to communicate accurately and concisely
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation for applicants with known disabilities or chronic illnesses during the recruitment process, where required