Senior Regional Medical Advisor - Italy

　　Location Milan, Italy

　　Requisition ID 2213

　　# of openings 1

　　Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1257)

　　Job Brief

　　Senior Regional Medical Advisor - Italy

　　SUMMARY OF POSITION

　　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.

　　With the agreement of the Country Medical Director, this position is accountable for developing and delivering a full range of Medical Affairs activities.

　　The successful candidate will have already gained an excellent working knowledge and be able to provide examples of best practice in Medical Affairs. They will demonstrate the ability to take responsibility for delivering key medical affairs activities; including but not be limited to running advisory boards, producing medical materials and medical education initiatives, delivering training, scientific symposia, publication work, maintaining a network of medical thought leaders. Where appropriate they will take a leading collaborative role in delivering health technology assessment submissions.

　　You should be seen as a leader in compliance and as the expert for the therapy areas you are responsible for. You must uphold the highest standards of compliance with all aspects of your work.

　　They will be looking to expand their current industry experience in a Medical Affairs role working in the exciting and evolving field of rare disease specifically lysosomal disorders.

　　They will provide technical/scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Amicus standards and regulations. They will have a have a strong scientific / medical background and be able to converse all levels.

　　ROLES AND RESPONSIBILITIES

　　Provide support to the Country Medical Director in developing and implementing Medical Affairs’ initiatives to support the needs of the affiliate including but not limited to:

　　· Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease, Pompe Disease and Batten Disease

　　· Take accountability for the development, oversight and execution of the medical plan.

　　· Lead on medical initiatives fully independently and with minimal support. Lead on the delivery of scientific discussions, presentations, data exchange and education with healthcare professionals.

　　· Support the Medical Director with the execution of the Medical Affairs strategy and support country marketing activities for all Amicus products, ensuring adherence to all Amicus policies and procedures as well as local regulatory, legal and compliance requirements.

　　· Provide operational support for activities related to Medical Information and Communication, Medical Education and Training, Clinical Trials (CTs) and Clinical Development support as needed.

　　· Provide medical leadership in obtaining health technology approvals for Amicus products, in partnership with Market Access

　　· Act as a leader within the country cross functional team with proficiency, with proven cross-functional working ability, directing strategy and fully accountable for medical decisions and strategic plans, including training of the broader commercial teams.

　　In addition to the above the role will be responsible for:

　　Note: the following percentages are an approximate guide to the allocation of time in each activity

　　· Thought Leader Engagement

　　· Develop and maintain excellent thought leader relationships in conjunction with the broader country team.

　　· Delivery of Advisory Boards

　　· Regularly attend events such as scientific meetings, conferences/symposia to interact with thought leaders and enhance disease area knowledge ensuring good quality feedback to relevant colleagues.

　　· Organise and run medical education meetings & initiatives.

　　· Support Amicus’ vision and goals through regular meetings with physicians and other key customers

　　· Medical Information and Communication

　　· Supports Medical Information enquiry handling process and advise on medical safety or clinical issues as required.

　　· Support congress medical information activities

　　· Provide literature analysis for Key Account Managers (KAMs), marketing, and customers.

　　· Ensure adverse events and pregnancy reports are duly processed in line with company procedures and assist in assessment of adverse event reports originating in the Country for completeness, consistency and reporting requirements.

　　· Medical oversight and review of promotional activities

　　· Able to apply good working knowledge of country [ABPI/IPHA] Codes of Practice and Amicus Standard Operating Procedures (SOP) and can advise on compliance issues and review promotional materials and activities.

　　· Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards.

　　· Ensure activities are aligned to company strategy.

　　· Assist medical director to ensure medical governance within the affiliate.

　　· Medical Training

　　· Medical training and clinical updates

　　· Develop slide decks for training activities and for the support of key customers.

　　· Develop expert knowledge of Amicus’ and competitor products and activities.

　　· Clinical Trial activity

　　· Contribution to the management of Investigator Initiated Studies (IIS)

　　· Contribute to the selection of potential study sites for development trials.

　　· Provide strategic input into the development and execution of local clinical trials, IIS activities and publication plans.

　　QUALIFICATIONS AND BACKGROUND REQUIREMENTS

　　Educational Requirements

　　· Advanced post graduate scientific degree or health care professional [Country specific degrees] MSc, MD, PhD)

　　Professional Work Experience

　　· Prior relevant experience as a medical advisor

　　· Pharmaceutical or Biotech industry experience preferred.

　　· Knowledge of national regulatory guidelines, [Medicines Act and the Human Medicines Regulations, ABPI /IPHA] Code of Practice and Standard Operating Procedures, and experience of their implementation within the business environment.

　　· Proven knowledge of medical affairs including clinical trial design, management, analysis and reporting, including GCP.

　　· Medical expertise ideally in lysosomal disorders.

　　· Experience in rare diseases would be an advantage.

　　· If a Healthcare professional, relevant level of clinical experience

　　· Must possess a good understanding of the healthcare environment within their country of responsibility.

　　· Experience in supporting clinical studies (phase III- IV, registries, investigator-initiated studies)

　　· Organisational, problem solving & collaborate cross functional working skills.

　　· Customer focus & timely results orientation approach

　　· Excellent interpersonal & team working skills.

　　· Project and time management skills

　　· Sociable, confident and outgoing

　　· Fluent in written and spoken English.

　　Travel

　　· Willingness to travel (mainly nationally but some limited international travel)

　　· 60% field/40% office

　　·

　　Other skills/Attributes

　　· Demonstrated alignment with Amicus Mission Focus Behaviours

　　· Passion for rare disease and patient focused.

　　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, disability status or any other characteristics protected by applicable federal, state or local law.

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