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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Investigational Product management, including sterile product preparation and compliance with GCP and ICH guidelines. Proficient in creating training materials and documentation for clinical research trials while ensuring adherence to regulatory standards.
Highest-signal resume keywords
Bachelor's Degree In PharmacyRelevant Experience In Clinical ResearchSterile Product PreparationGood Clinical Practices (GCP)Investigational Product 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
Investigational Product PreparationPharmacy Manual ComplianceAncillary Supply Database ManagementTechnical Documentation ReviewClinical Trial Design Understanding
Soft Skills
CollaborationProblem-SolvingCommunication
Tools & Technologies
Veeva
Industry Keywords
Clinical ResearchPharmaceutical IndustryCFR ComplianceICH E6 GuidelinesPharmacy Background
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support activities related to preparation and administration of Investigational Product used in clinical research trials across multiple therapeutic areas
- Create documentation and training materials to uphold Investigational Product management standards
- Prepare pharmacy manuals and related documentation
- Assist clinical site research pharmacists with pharmacy manual compliance
- Collaborate with DPDT, Regulatory Sciences/Affairs, Clinical Trial Management, Clinical Study Lead, Study Medical Director, Clinical Scientist and Quality Management Lead
- Support creation of Kick-off meeting and Site Initiation Visit materials
- Perform internet and literature searches for ancillary supplies compatibility information
- Contact manufacturers, enter and maintain ancillary supply database information, and support assessment and procurement
- Obtain and complete pre-pharmacy manual documentation, including design of Investigational Product preparation
- Perform technical and consistency reviews of pharmacy manuals and related documentation
- Respond to clinical site pharmacist and internal clinical team mailbox inquiries
- Maintain department-related materials in Veeva
- Prepare training materials and participate in Site Initiation Visits and Investigator meetings
- Provide study-specific pharmacy training to site monitors and participating sites
- Determine, resolve and/or escalate quality, preparation, administration, handling, ancillary supply, regulatory filing and pharmacy manual issues
Requirements
What you’ll need- Bachelor's degree in Pharmacy and/or Nursing plus 6+ years relevant experience, or PharmD plus 4+ years relevant experience
- Relevant experience in hospital or clinical research, IDS pharmacy or equivalent pharmaceutical/biotech industry experience is helpful
- Demonstrated experience with sterile product preparation or administration as a pharmacist or nurse
- Good understanding of Clinical Supplies / Clinical Trial design
- Working knowledge of GCP and ICH guidelines
- AI usage experience is helpful
- Pharmacy or nursing background and experience
- Compliance with applicable federal (CFR and ICH E6) and state regulations, international standards and regulations, good clinical practices, and institutional policies and procedures
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 during the recruitment process where required