Senior Regional Medical Advisor – Central/South Germany

Amicus Therapeutics, Inc.; Germany (OH); On-site; USD 104,000 - 150,000; Full time

Job summary

A global biotechnology company is seeking a Senior Regional Medical Advisor to support the portfolio with clinical insights and execute the Medical Affairs strategy. This role involves collaborations with healthcare stakeholders, organizing medical events, and maintaining compliance with regulations. Candidates should hold an advanced biomedical degree and have experience in medical affairs, preferably within rare diseases. Fluency in German and English is essential.

Qualifications

• Experience in rare diseases is preferred.
• Medical Affairs experience within biotechnology or pharmaceutical industry preferred.
• Knowledge of applicable German pharmaceutical regulations.
• Strong knowledge of German pharmaceutical regulations and guidelines.
• Excellent communication and interpersonal skills; fluent in German and English.

Responsibilities

• Identify and develop scientific collaboration with external physicians.
• Serve as the primary Amicus medical affairs representative.
• Organize standalones, satellite symposia, and AdBoards.
• Lead Medical operations in Market Access proceedings.
• Drive ongoing clinical trial activity at study sites as directed.
• Collect and report clinical insights to internal teams; maintain up-to-date medical knowledge.

Skills

Excellent verbal/written communication

High proficiency of German and English

Proven planning and organizational skills

Strong business acumen

Medical terminology

Team collaboration

Education

Advanced biomedical sciences degree (Dipl., MD, PharmD, PhD)

Job description

Overview

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

The Senior Regional Medical Advisor (SRMA) will work as a member of the Medical team to support Amicus portfolio with products in different phases of lifecycle and relay field-based clinical/medical insights back to Amicus to impact the future strategy so Amicus can continue to bring innovative medicines to patients with rare diseases.

€0 - €0 a year

Based on the Director Medical Affairs advice and in close cross-functional alignment, the SRMA will help to execute the Medical Affairs strategy and support the German cross functional activities for all Amicus products. The position will provide operational support for activities related to Medical Information and Communication, Medical Education and Training, Investigator Initiated Trials, Key Opinion Leader outreach bringing value via scientific exchange. The position will also provide Research & Clinical Development support as needed. The SRMA will support the Director Medical Affairs Germany in all aspects, i.e. representation of Amicus in scientific presentations, conferences, and support for the Commercial Organization while ensuring compliance with all Amicus policies and procedures as well as local regulatory and legal requirements.

Roles and Responsibilities

• Systematically identify and develop new as well as maintain and enhance existing scientific collaboration and exchange with external physicians, genetic counsellors, nurses, payers, pharmacists, scientific experts, hospital teams, educators and investigators within a defined geography (Central/South Germany) and therapeutic area.
• Serve as the primary Amicus external medical affairs representative for assigned key stakeholders, providing deep and advanced disease state and product information as well as facilitating collaborations aligning with Amicus’ strategic goals.
• Independently and responsibly organize standalones, satellite symposia and AdBoards (full project and content management).
• Function as Medical operational lead in Market Access proceedings.
• Drive ongoing clinical trial execution at study sites as directed by internal clinical operations colleagues.
• Consistently collect, report and represent clinical insights and unanswered questions received from external contacts to the appropriate channels internally.
• Understand and effectively communicate current scientific knowledge.
• Build and maintain technical and clinical expertise across therapeutic areas to engage in deep scientific discussions.
• Engage in continuous learning within the therapeutic area.
• Attend appropriate scientific meetings, conduct routine literature searches, and communicate regularly with the Medical Team to share learnings.
• Establish oneself as a reliable, trusted resource of accurate, up-to-date medical and scientific knowledge for clients.
• Promptly respond to personal or electronic inquiries with any available information which may include reprints or posters, medical letters, literature citations, access to internal and external experts, slides and other related material.
• Manage relationships with hospital pharmacy directors, Medical Directors and payer thought leaders to provide requested disease state, epidemiologic, diagnosis and relevant treatment education. Work with the commercial team to communicate science and clinical trial results in a fair and balanced manner.
• Partner and collaborate with Amicus Patient and Professional Advocacy (P&PA) in developing and maintaining partnerships with advocacy groups across therapeutic areas.
• Seek clarification from management and/or Compliance & Legal when uncertain whether a proposed activity could violate Amicus policy or the law.
• Facilitate access to educational grant request process and align Investigator-Initiated Program (IIP) activities with internal areas of scientific interest.
• Prompt intake and responses for medical information and requests for Medical Affairs support.
• Provide ongoing disease and product training to internal and field personnel.
• The SRMA role entails not only scientific and customer expertise, but also requires the ability to understand and effectively utilize approved resources to fulfil administrative, procedural, and legal requirements in order to address customer needs. These activities may include proficiency in computer skills and database entry, continual compliance of all procedural requirements of the role and appropriate utilization and best practice sharing of available resources.

Requirements

• Educational Requirements
• Advanced biomedical sciences degree (Dipl., MD, PharmD, PhD)
• Medical Affairs experience within biotechnology or pharmaceutical industry and a record of significant accomplishment (e.g. project management) is preferred
• Experience in rare diseases is preferred
• Embrace the Amicus Mission Based Behaviours and Core Values as a patient-centric global biotechnology company
• Professional Work Experience Requirements
• Knowledge of applicable German pharmaceutical regulations as well as other industry rules and guidelines
• Strong business acumen; has understanding of the multi-disciplinary functions involved in a company\'s drug development process, e.g. research, development, clinical operations, biostatistics, regulatory, commercial
• Medical and clinical terminology knowledge
• Organizational experience in Medical projects incl. AdBoards, standalones, workshops, symposia is a plus
• Experience and Skills
• Excellent verbal/written communication and listening skills
• High proficiency of German and English language
• Proven planning and organizational skills; excellent communication skills
• Proven ability to collaborate and make connections with both internal and external stakeholders
• Stellar interpersonal skills, customer focus and emotional intelligence in developing and maintaining professional relationships
• Thrives in and actively supports a team environment
• Proven self-starter that is solution focused when presented with challenges
• Ability to manage a moving schedule, and adapt and be flexible as needed with evolving priorities
• Other skills/Attributes
• Demonstrated alignment with Amicus
• Demonstrated alignment with Amicus Mission Focus Behaviours
• Passion for rare disease and patient focused
• Travel
• Occasional presence at scientific conferences or symposia and local Amicus lead Medical events, as well as at some internal meetings will be required.
• Overall, estimated travel on average will be up to 60%, of which at least a third as single day trips.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement. Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, colour, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran status or any other characteristics protected by applicable federal, state or local law.