Exemption Access Programs Manager - Paris, France - Amgen

Amgen

Entreprise vérifiée

Paris, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

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 kickoff and followup meetings + minutes delivering and archiving with all collaborators (local cluster team, global team and vendor)
Coordinate 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 crossfunctional programspecific 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 followup 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, worklife 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