Manager US Medical Review MMRC
Manager US Medical Review MMRC
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Salary Not Disclosed
1 Vacancy
Job Description
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multidimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our firstinclass neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company one that maintains its roots as a sciencebased startup and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.
The Manager US Medical Review MMRC will serve as a Medical Affairs member of the US Medical Materials Committee (MMRC).
This position will report to the Head of USMA Integrated Medical Capabilities and be part of the Medical Review Community.
The Manager US Medical Review MMRC will be responsible for the Medical Review of Medical Affairs Materials to ensure the communication of accurate consistent and timely information regarding products and therapeutic areas. This includes providing solutionsoriented feedback and working collaboratively within the Medical Review Community including the AD US Medical Review and other crossfunctional team members such as: Medical Legal and Regulatory. The Manager US Medical Review will maintain ongoing communication across the Medical Review Community.
ROLES & RESPONSIBILITIES
Serve as the Medical Reviewer for scientific accuracy in the US Medical Materials Committee (MMRC)
- Provide independent medical review to ensure statements are scientifically valid and accurate truthful and not misleading including the appropriateness of references cited
- Identifies and communicates challenges to AD US Medical Review
Effective ongoing communication and collaboration within the Medical Review Community including Medical Affairs Project Owners
Communicate and collaborate effectively with crossfunctional teams to cultivate a positive relationship
Maintain scientific knowledge including labeling associated therapeutic areas relevant literature treatment guidelines and competitor information through ongoing internal and external data sources (e.g. training conferences)
Fully comply with all argenx policies and applicable laws regulations and ethical standards and make decisions within guidelines and policies
SKILLS AND COMPETENCIES
Able to partner with internal stakeholders and embrace crossfunctional working
Strong operational capabilities eye for detail and commitment to advance and adhere to processes
Ability to critically evaluate literature interpret complex data write effectively articulate information to a variety of audiences and negotiate with counterparts from crossfunctional areas
Must be a strong team player with a positive attitude and demonstrate flexibility to plan and prioritize in a dynamic environment
Ensures the highest degree of quality and medical accuracy for all outputs developed
Completes all work in accordance with regulatory requirements industry standards and argenx policies
REQUIREMENTS
Doctorate Degree (PharmD/MD/PhD)
12 years biopharmaceutical industry in medical affairs leading the review of marketing and/or scientific communications
Experience in content management systems (Veeva Vault or similar) is preferred
Strong scientific/medical written and verbal communication skills required
At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application interviewing or otherwise participating in the candidate selection process please contact us at . Only inquiries related to an accommodation request will receive a response.
Required Experience:
Manager
Employment Type
Full-Time
