Exemption Access Programs Manager

Committed to research, Amgen is just as committed to its employees and the environment Because we believe in a world where everyone can be themselves and play a role, AMGEN France is socially committed through its Committed4Good programme. In 2021, AMGEN signed its first LGBT+ charter and the following year was awarded the "Very High Health, Social and Environmental Quality" label, making Amgen France the first pharmaceutical company to be awarded this label. This label underlines our commitment to taking account of environmental, societal, social, health, ethical and economic aspects in our day-to-day operations and professional practices. **EXEMPTION ACCESS PROGRAMS MANAGER - H/F** **LIVE** **What you will do** - Serve as operational point of contact to partners and across functions for Derogatory Access (DA) programs (Compassionate use, AP1 and AP2) - Lead planning, management and oversight of DA programs execution in accordance with the local strategy and SOP through leadership & engagement of the local cluster DA team - Deliver and ensure retro planning according to local SOP and submissions timelines and track activities for each DA program - Track program progression in appropriate systems and archive all documentations - Organize kick-off and follow-up meetings + minutes delivering and archiving with all collaborators (local cluster team, global team and vendor) - Co-ordinate and participate to all activities related to deliverables: PUT-RD/PUT-SP, CRF, information letter, documentation for HA submission, translation of documents to be approved by the global CfOr team, data review, statistical and clinical reports - Primary point of contact of the vendors involved in the program & Manage, oversee and monitor applicable vendor activities - Participate to build the call for tender to select the vendor (s) to be involved in the project - Partner with team members to ensure timely and appropriate DA deliverables - Responsible for compiling and submitting documents which must be internally or externally approved in due time - Organize, lead, participate and deliver minutes for local cluster team meetings, meetings with the global team and meetings with the vendors - Identify, raise and facilitate resolutions of cross-functional program-specific issues. - Communicate country status (including timelines and deliverables) to key partners internally and externally - Support internal audit and inspection activities on DA programs - Supervise the SCBA activities (negotiation of the contracts with vendors and convention with centers and follow-up of the budget) **WIN** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills: - PharmD, PhD or master degree in science - 3 to 4 years experience in clinical research as project manager or management of Derogatory Access (DA) programs with a part of project management - Experience working effectively in a team/matrix environment - Ability to understand technical, scientific and medical information - Working knowledge of the French regulatory ecosystem - Advanced computer skills including databases - Ability to write and present clearly using scientific and regulatory terminology in local language and in English - Clinical research regulation - Derogatory Access regulation - Data privacy - Management - Strong Organizational and planning skills - Relationship management - Time management and prioritization - Flexibility - Written and oral communication skills including in English - Problem solver - Effective communication across all levels within an organization - Standout colleague with the ability to take initiative and lead **THRIVE** **A corporate culture and many benefits that make the Amgen difference** Just as we strive to develop innovative therapies to treat patients with serious diseases, we strive to ensure the professional and personal growth and well-being of our employees. - Our team structures offer Amgen employees the opportunity to influence the direction of the company, gain a broader perspective on other roles within Amgen and reach their full potential. - Many opportunities to learn and grow within a global organisation. - A diverse and inclusive community where team members have the opportunity to contribute ideas and take action. - A generous total rewards package including health, financial and wealth benefits, work-life balance and career benefits. **APPLY NOW** Join us in our quest to serve patients. **AMGEN IS COMMITTED TO FAIRNESS AND EQUAL OPPORTUNITIES** Amgen is committed to fair treatment and the integration of diversity and inclusion of workers with disabilities and opens all its positions to them. If you have a disability, do not hesitate to inform your Human Resources contact of any adaptations or tools required for the interview to run smoothly. If you have any specific questions relatin