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Associate Director, Medical Affairs

External
ptcbio logoPtcbio · Rome, Italy
Full-timeOn-siteToday
ComplianceLeadershipSAFeTechnical Writing
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About the role

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: www.ptcbio.com Job Description Summary: The Associate Director, Medical Affairs is responsible for providing strategic and operational leadership to the Medical Affairs plan and supporting marketed/pipeline products and specific activities and strategic projects. Job Description: Responsibilities of the role include: Adapts global and regional Medical Affairs strategies to ensure suitability in the designated territories. Identifies, organizes, and ensures successful execution of the tactical implementation of medical affairs strategy. Ensures adherence to relevant regulatory requirements, company SOPs and industry codes of conduct as appropriate. Identifies thought leaders, ensuring a focused communication and build long term interaction with key KOL regarding current and future Rare Diseases in PTC's areas of interest (e.g. PKU, DMD/Ataluren; AADC area; Gene therapy, etc.) through highly scientific disease state and medicines discussions that support and ensure safe and effective utilization of products. Requires both internal cross-functional and external KOL/stakeholders collaborations (e.g. local/regional advisory boards, educational forums, clinical interaction with payors). In collaboration with commercial/marketing teams ensure that the regional/local strategic medical affairs plan is in line with the marketing plans/brand strategies. Responsible for review and local adaption of global materials and scientific content of promotional and non-promotional materials such as training material, slide decks, brochures to inform HCPs, homepage materials, etc. with particular regard to medical accuracy and compliance to local regulations and codes of practice. Provides support to other internal departments (i.e. Market Access, Regulatory, Pharmacovigilance, Legal, Compliance, etc.) as needed. Provides training and scientific education to commercial, medical team and other internal and external stakeholders. Supports national and international congress activities and is responsible for medical activities such as symposium content, speaker briefing and poster presentations at congresses. Acts as content manager screening recent publications in the related scientific area and streamlining content, inform team members on literature updates and be responsible for the national licensing process of literature to be shared with internal and external stakeholders. Work-up specific scientific topics of interest and deliver literature summaries. Recruits, manages, coaches and develops direct reports (if applicable). Performs other tasks and assignments as needed and specified by management. Requirements for the role include: An advanced degree (e.g., Masters, PharmD, M.D. or Ph.D.) in a scientific discipline and demonstrated experience of progressive responsibility in, pharmaceutical, biotechnology or related environment with a minimum of 4-5 years medical affairs experience or equivalent combination of education and experience. Demonstrated success in interpreting scientific data and presenting research information to scientists and HCPs. Experience dealing with the local regulatory authorities and payor organizations. In-depth experience adapting regional plans to a country orientation, while working within a global framework. Excellent working knowledge in local regulations and codes of practice as well as a good understanding of the market and medical dynamics in the designated territory. Ability to influence without direct authority. Proficiency with Microsoft Office. Excellent verbal and written communication and skills, including scientific/technical writing and presentations with the ability to communicate complex technical information clearly. Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Demonstrates leadership and the ability to manage and coach direct reports. Fluent in Italian and English (written and verbal). * Travel requirements. Flexibility to travel domestically and internationally as needed by the business EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gende


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