8 community care coordinator jobs found

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

In this role, you will be at the forefront of developing and implementing innovative contract models tailored to our diversified oncology portfolio. You will build and maintain long-term business relationships with key stakeholders, specifically in the hospital, GPO, and wholesale segment, analyze market trends, and provide strategic input to drive our business forward. A typical day might include the following: Negotiation and conclusion of contracts primarily with hospitals, purchasing groups (GPO), and regional and national health insurance funds across Germany. Developing and implementing innovative contract models tailored to our oncology portfolio. Establishing and maintaining long-term business relationships with key stakeholders in the healthcare sector. Analysis and evaluation of market trends and competitive activities to optimize negotiation strategies. Development of education and training concepts for the internal Commercial team as well as external...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

The Senior Manager, Global Procurement – Supplier Quality Compliance will be responsible for leading a small team of Global Procurement Compliance professionals that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. A typical day may include: Tracks progress on all Global Procurement quality system deliverables, including deviation investigations, CAPAs and change controls, ensuring quality and accuracy of documentation as well as adherence to established due dates Interfaces regularly with Quality Assurance and...

The Medical Affairs HCP Engagement Temp will provide project management support for international markets on HCP Engagements and sponsorships. This position reports to the Sr. Manager of Medical Affairs Business Operations. What a typical day may look like; Coordinate the complete contracting process for members of the healthcare community within international countries. Serve as the primary point of contact for medical teams seeking mentorship and support on contracting processes related to HCP engagements and sponsorships. Provide training on processes to relevant teams and collaborate with the Sr. Manager to develop and maintain resources, web pages, training materials, and quick reference guides. Stay informed about company policies, procedures, and government regulations related to HCP engagements and sponsorships.  Conducting regular reviews and supporting internal audits. Handle relationships with key internal stakeholders, including...

Within this role you will be responsible for coordination and completion of manufacturing deviations and change controls.   As an Associate / Compliance Specialist a typical day might include, but is not limited to, the following:   ·          Coordinating and documenting of manufacturing quality events including but not limited to deviations and change control’s ·          Coordinating cross functional teams during Change Control/Deviation events and align team on approach forward ·          Utilizing problem solving methodologies such as fishbone, 5 Whys to establish root cause of deviations ·          Working closely with Manufacturing Managers to review and evaluate quality event information ·          Assessing event for impact to SISPQ, conduct risk assessments and initiating appropriate corrective actions to prevent recurrence ·          Coordinating of internal reviews of investigational reports ·...

Regeneron is looking for a Compliance Specialist to join our Process Sciences Change Management team. This is a non-lab-based position.  This position will be responsible for supporting the Process Sciences, Manufacturing, and CMC Regulatory departments through the development of strategic plans to support change management activities and documentation related to implementation and maintenance of process control programs for bulk drug substance / formulated drug substance, drug product, combination product, and advanced therapies manufacturing bioprocesses. In this fast-paced environment with a strong pipeline, our Compliance Specialists have an opportunity to work on countless aspects of the process and business. As a Compliance Specialist, a typical day might include the following: Craft business plans to independently advance change control initiatives to implement lifecycle activities of established manufacturing control strategies in support of Global Process...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...