Medical Advisor
Il y a 6 mois
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to us becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Medical Advisor - Rare Diseases
**Live**:
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will be at the forefront of providing authoritative medical expertise specifically tailored to the complex landscape of rare diseases. Your expertise will contribute significantly to the development, promotion, and compliance of medical products and practices:
**Rare Disease Expertise**:
- Develop and maintain a deep understanding of the pathophysiology, treatment modalities, and emerging therapies for Amgen’s rare disease portfolio.
- Provide specialized medical insights to the internal cross-functional team, ensuring alignment with the outstanding challenges posed by rare diseases.
- Develop a strong knowledge in rare diseases and act as a strategic partner to internal and external stakeholders.
- Provide medical expertise for pipeline products/Health Economy and reimbursement requests.
- Approve scientific content of local symposia/ scientific events/ publications/ promotional materials/medical section of reimbursement files.
- Provide input to help shape the strategy for innovation projects.
**Clinical Research**:
- Collaborate with research and development teams to assess the feasibility and potential of new therapies for rare diseases.
- Stay actively involved in the design, follow-up and interpretation of clinical trials focused on rare diseases.
- Review local Investigator Sponsored Study proposals prior to approval and ensures appropriate local review prior to submission to review comité, if applicable.
- Provides input into site selection for AST’s (Amgen sponsored studies)
- Work with Local study team to ensure preparation, implementation and completion of AST’s
- Develop and implement better recruitment strategies in conjunction with local study team
**Compliance**:
- Ensure all medical practices and products related to rare diseases follow specific regulatory standards and requirements.
- Play a key role in preparing and reviewing documentation specific to rare disease indications
**Educational Outreach**:
- Conduct specialized training sessions for internal teams, emphasizing the nuances of rare diseases and their management.
- Establish and manage relationships with key opinion leaders (+/-50% field based) and healthcare professionals specializing in rare diseases.
**Risk Management**:
- Identify and assess potential risks associated with therapies for rare diseases, developing risk mitigation strategies.
- Provide advice on adverse event reporting and management specifically related to rare disease treatments.
**Define the medical strategy**:
- Work closely with cross-functional teams to integrate insights into the development and promotion of products targeting rare diseases.
- Collaborate with external partners within the rare disease space, including healthcare professionals, patient advocacy groups, and regulatory agencies.
- Partner with the Product Manager for the development of the Local product(s) lifecycle management plan
- Co-lead the brand meetings
- Leads and develops the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations
- Identify local data gaps, medical needs, study/research planning
- Align the local medical plan with the local commercial plan and the global medical plan
- Conducts National and/or Regional Advisory Board Meetings
**Win**:
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
**Qualifications**:
- Medical education or scientific background and scientific expertise in rare (neuro-)inflammatory diseases
- Substantial experience in a medical advisory role or previous experience as medical science liaison
- In-depth knowledge of clinical research, regulatory affairs, and healthcare compliance related to rare diseases.
- Strong communication and presentation skills, with the ability to convey sophisticated medical information clearly.
- Consistent track record of collaboration with key opinion leaders and experts in the field of rare diseases.
- Minimum of 3 years of experience in pharmaceutical industry within medical affairs
- Fluent in Dutch, French and English
**Thrive**:
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and
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