You haven't searched anything yet.
This position can be fully remote
PURPOSE AND SCOPE:
Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for assigned projects. Prepares for agency interactions by writing and organizing associated documentation, including letters and briefing packages. Reviews and advises on manufacturing and control changes for marketed products, labels and clinical materials for products in development.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
EDUCATION:
Bachelor’s Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
Full Time
$100k-127k (estimate)
03/17/2024
07/20/2024
DENVER, CO
25 - 50
2010
DAN KNACK
$10M - $50M