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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical information management, compliance with global medical guidelines, and effective communication of technical information. Proven ability to lead cross-functional teams and manage complex processes within the pharmaceutical industry.
Highest-signal resume keywords
Advanced Degree In Relevant Medical SpecialtyClinical Experience In Pharmaceutical IndustryMedical Affairs ExperienceRegulatory Affairs InteractionStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical Information ManagementPharmacovigilancePost-Market SurveillanceScientific EvaluationTechnical Writing
Soft Skills
Problem SolvingOrganizational SkillsRelationship BuildingTeam Management
Certifications & Qualifications
Healthcare Certification
Industry Keywords
FDA InteractionMedical CommunicationsCompliance StandardsSOP MaintenanceCross-Functional Collaboration
About the role
Key responsibilities & impact- Lead the medical information team
- Ensure compliance and trending of medical information inquiries with company procedures
- Compose and maintain standardized response letters and serve as their business owner
- Independently review and critically evaluate medical/scientific literature on company and competitor pharmaceutical products
- Support medical review of company medical and promotional materials
- Participate on cross-functional product development and support teams
- Provide professional consultation regarding safety, efficacy, and proper product usage
- Support Pharmacovigilance and Product Monitoring activities, including Health Hazard Evaluations and customer letters
- Serve on the Signal Action Committee reviewing safety signals
- Comply with global medical information guidelines, standards, and regulations
- Maintain SOPs for responding to unsolicited global medical information requests
- Collaborate with Legal, Regulatory Affairs, R&D, Engineering, Business Development Leadership, Commercial, Pharmacovigilance, and Customer Service
- Guide and monitor the call center and medical information vendor/CRO, including product labeling and policy adherence
- Perform internal quality assessments and medical review of information provided by company personnel
- Act as medical information subject matter expert during audits and regulatory inspections
- Draft audit and inspection responses and assist with corrective actions
- Prepare and deliver regular and ad-hoc medical information and post-market reports
- Identify performance issues and alert appropriate management
- Identify, hire, train, develop, and manage medical information specialists
- Report to the Product Monitoring and Medical Information Lead
- Manage a team of professional individual contributors
Requirements
What you’ll need- Advanced degree in relevant medical specialty required (i.e. PharmD, RPh, Physician’s Assistant (PA), etc.)
- Minimum of five years of clinical/practical experience in a relevant clinical environment or related Post-Market Surveillance experience in the pharmaceutical and/or medical device industry
- Healthcare certification preferred
- Previous Medical Affairs, Regulatory Affairs, and/or Medical Communications experience in the pharmaceutical industry preferred
- Experience interacting with regulatory agencies such as the FDA preferred
- Writing skills necessary to effectively communicate technical/clinical information
- Strong communication and presentation skills
- Problem solving and scientific evaluation skills
- Sound organizational skills with the ability to prioritize tasks
- Ability to build productive relationships with personnel within and outside of the department and company
- Demonstrated ability to manage complex processes and cross-functional teams
Benefits
Comp & perks- Occasional travel may be required for training seminars, manufacturing site visits, and professional/trade conventions