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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical affairs with a focus on paediatric hepatology and cholestatic liver diseases, ensuring compliance with regulatory standards and effective stakeholder engagement. Capable of developing and executing medical strategies, providing scientific support, and leading cross-functional initiatives.
Highest-signal resume keywords
Medical Affairs ExperiencePaediatric Hepatology ExpertiseKOL EngagementRegulatory Compliance KnowledgeCross-Functional Team Collaboration
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 Strategy DevelopmentClinical Study SupervisionEvidence GenerationData AnalysisStakeholder Insight Collection
Soft Skills
Excellent Communication SkillsInterpersonal SkillsInfluencing SkillsIndependent Work AbilityConstructive Feedback Provision
Tools & Technologies
GxP ComplianceGCPGPvPGMPGDP
Certifications & Qualifications
Medical DegreePharmacy DegreePhD
Industry Keywords
Cholestatic Liver DiseaseRare DiseaseHepatologyGastroenterologyMedicines Australia Code of Conduct
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide strategic and tactical medical expertise across the assigned therapy area and territory
- Develop and maintain partnerships with Thought Leaders and key stakeholders in paediatric hepatology/gastroenterology and rare cholestatic liver diseases
- Contribute to medical strategy and cross-functional programs for the Country Brand Operating Plan for Bylvay
- Provide non-promotional scientific, medical, and educational support to Healthcare Professionals and other stakeholders
- Respond to unsolicited scientific and clinical information requests regarding Bylvay and cholestatic liver disease
- Communicate scientific, clinical, and technical topics in line with Ipsen SOPs and the Medicines Australia Code of Conduct
- Organise and provide scientific support for advisory boards, round-tables, disease education meetings, congress activities, and satellite symposia
- Maintain deep knowledge of Bylvay, cholestatic liver disease, standards of care, and evolving evidence
- Support brand strategies, Country Brand Operation Plans, medical tactics, and budget management
- Collect stakeholder insights and support Market Access and Patient Affairs with clinical and HEOR data
- Advise Brand teams on medical and regulatory approaches
- Review and approve promotional materials from a medical perspective
- Develop and execute KOL engagement plans and identify speakers
- Deliver medical training to internal staff
- Supervise evidence-generation projects, clinical studies, registries, real-world evidence, and outcomes/quality-of-life projects
- Act as key contact for HQ Clinical Operations and contracted CRO companies
- Lead and supervise Grants and CSS/ISS/data-generation execution
- Support Regulatory and Pharmacovigilance activities, including adverse-event and technical-complaint reporting
- Serve as designated backup for local medical information and pharmacovigilance activities
- Ensure scientific support complies with EFPIA codes, regulatory rules, and Ipsen SOPs
Requirements
What you’ll need- At least 5 years of experience in the pharmaceutical industry in a Medical Affairs role
- Specialisation in rare disease and/or paediatric specialty care and cholestatic liver disease preferred
- Strong existing network of KOLs and key stakeholders, especially in paediatric hepatology and gastroenterology, liver transplant/referral centres, and rare disease networks
- Current training in international/local studies and GxP, including GCP, GPvP, GMP, GDP, and other applicable instruments and regulations
- Understanding of the drug development process
- Good knowledge of the therapeutic area; hepatology/gastroenterology and/or rare cholestatic liver disease experience advantageous
- Demonstrated experience working successfully with cross-functional teams
- Ability to elicit audience knowledge gaps and customise presentations to communicate appropriate scientific data
- Ability to work independently with minimal supervision
- Ability to provide constructive advice and feedback on strategies and actions
- Knowledge of the Medicines Australia Code of Conduct
- Excellent verbal, written, interpersonal, and influencing skills
- Medical, Pharmacy, or PhD degree
- Knowledge of and compliance with relevant regulatory, ethical, pharmacovigilance, and company SOP requirements
Benefits
Comp & perks- 12-month fixed term contract for maternity leave cover
- Inclusive workplace supporting diversity, equal opportunities, and employee wellbeing
- Adjustments or support available during the application process