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Expanded Access Manager Jobs (NOW HIRING)

Sunshine Behavioral Health

Patient Access Manager

OR · Remote

$70K - $80K/yr

... expanding company objectives. Responsibilities: * Oversee patient access functions, including ... Manage and support revenue cycle processes, with a focus on front-end optimization and workflow ...

Ardelyx

Zone Access Manager - Nephrology

San Jose, CA · On-site

Zone Access Managers serve as a dedicated point of contact for Ardelyx Area Business Directors ... Maintain and expand knowledge of national, regional, local, and account-level market dynamics ...

New

Ambu

Market Access Manager

Columbia, MD · On-site

The Market Access Manager will have a unique opportunity to help shape and expand market access strategy across Ambu's endoscopy, anesthesia, and patient monitoring portfolio. Leveraging a strong ...

Ardelyx

Zone Access Manager - Nephrology

Los Angeles, CA · On-site

$131K - $160K/yr

Zone Access Managers serve as a dedicated point of contact for Ardelyx Area Business Directors ... Maintain and expand knowledge of national, regional, local, and account-level market dynamics ...

Ardelyx

Zone Access Manager - Nephrology

San Jose, CA · On-site

$131K - $160K/yr

Zone Access Managers serve as a dedicated point of contact for Ardelyx Area Business Directors ... Maintain and expand knowledge of national, regional, local, and account-level market dynamics ...

Ardelyx

Zone Access Manager - Nephrology

San Jose, CA · On-site

$131K - $160K/yr

Zone Access Managers serve as a dedicated point of contact for Ardelyx Area Business Directors ... Maintain and expand knowledge of national, regional, local, and account-level market dynamics ...

New

Ardelyx

Zone Access Manager - Nephrology

Los Angeles, CA · On-site

$131K - $160K/yr

Zone Access Managers serve as a dedicated point of contact for Ardelyx Area Business Directors ... Maintain and expand knowledge of national, regional, local, and account-level market dynamics ...

New

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Expanded Access Manager information

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How much do expanded access manager jobs pay per hour?

As of Jun 6, 2026, the average hourly pay for expanded access manager in the United States is $23.12, according to ZipRecruiter salary data. Most workers in this role earn between $19.47 and $24.76 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an Expanded Access Manager, and why are they important?

To succeed as an Expanded Access Manager, you need expertise in regulatory affairs, clinical research processes, and a thorough understanding of expanded access programs, typically supported by a degree in life sciences or a related field. Familiarity with regulatory submission platforms, clinical trial management systems (CTMS), and compliance frameworks such as FDA and EMA guidelines is crucial. Strong project management, communication, and stakeholder engagement skills help navigate complex processes and align diverse teams. These competencies ensure timely patient access to investigational therapies while maintaining regulatory compliance and effective collaboration across stakeholders.

What is the difference between Expanded Access Manager vs Clinical Trial Coordinator?

AspectExpanded Access ManagerClinical Trial Coordinator
CredentialsTypically requires a bachelor's degree in life sciences, healthcare, or related field; certifications in clinical research are commonRequires a bachelor's degree in health sciences, nursing, or related field; certifications like CCRP are advantageous
Work EnvironmentWorks primarily in pharmaceutical or biotech companies, managing access programs for investigational drugsWorks in clinical settings or research sites, coordinating trial activities and patient enrollment
Employer & IndustryPharmaceutical companies, biotech firms, healthcare organizationsResearch institutions, hospitals, clinical research organizations

The Expanded Access Manager focuses on managing patient access to investigational drugs outside clinical trials, ensuring regulatory compliance. In contrast, the Clinical Trial Coordinator manages the day-to-day operations of clinical trials, including patient recruitment and data collection. Both roles require knowledge of clinical research processes but serve different functions within the drug development and healthcare landscape.

What is an Expanded Access Manager?

An Expanded Access Manager is a professional who coordinates and oversees programs that provide patients with access to investigational drugs or therapies outside of clinical trials, typically when no comparable alternatives are available. They work closely with healthcare providers, regulatory agencies, and pharmaceutical companies to ensure compliance with legal and ethical guidelines. Their responsibilities often include managing applications, tracking patient outcomes, and ensuring that all expanded access requests are handled efficiently and in accordance with regulatory standards.

What are some common challenges faced by Expanded Access Managers when coordinating compassionate use programs?

Expanded Access Managers often face challenges related to balancing regulatory compliance with timely access to investigational therapies for patients in need. They must navigate complex documentation requirements, coordinate closely with cross-functional teams such as regulatory affairs, medical, and legal, and ensure all stakeholders are aligned throughout the process. Additionally, handling urgent requests while maintaining thorough communication with healthcare providers and patients can be demanding, requiring strong organizational and interpersonal skills.
Senior Manager, Medical Operations, Expanded Access Programs

Senior Manager, Medical Operations, Expanded Access Programs

Regeneron Pharmaceuticals, Inc.

Sleepy Hollow, NY • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 23 days ago

Regeneron rating

8.7

Company rating: 8.7 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

14th of 71 rated pharmaceutical

Job description

The Senior Manager, Expanded Access Programs will be responsible for all operational aspects of multiple projects/programs such as Expanded Access Programs, individual patient expanded access, and post-trial access managed by Medical Affairs. Based on team assigned, this role may include supervision of staff. Additionally, this role will support other MA projects, as requested.
As a Senior Manager, a typical day may include:
Program Management:
  • Operational responsibility across multiple projects/program(s) with minimal direction: Expanded Access Programs, individual patient expanded access, post-trial access

Meetings & Committees:
  • Participates in team review meetings, product team alignment meetings, and program budget & status update meetings as needed

Budget Management:
  • Accountable for financial forecasting accuracy of Managed Access Programs within span of responsibility
  • Maintenance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforested as necessary, and brand give back are fully assessed
  • Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies

Drug Supply:
  • Responsible for managing drug supply for Expanded Access Programs and individual patient expanded access, as appropriate

Metrics & Reporting:
  • Responsible for ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays, solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities

Vendor Management:
  • Manages vendors and financial tracking as required per program

Essential Documents:
  • Ensures appropriate archiving of projects'/programs' essential documents

Systems Management:
  • Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency, including but not limited to:
  • Ensures ongoing QC of SharePoint document storage for completeness and audit readiness
  • Expertise required in the utilization of QlikSense, QlikView, SharePoint, Oracle and ESRA portal to support team needs

Process:
  • Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance. Exercises' judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions; Continued process improvements

Organizational goals:
  • Development of objectives in order to quantify success and attainment of goals. Ensures optimal structure, procedures, and adequate resources supporting growth of multiple projects/programs. Knows when to escalate issues, and involve senior levels of management to obtain adequate resolution

Alliance Management:
  • Ensures financial transparency and alignment with both Alliance and internal stakeholders, supporting the product team financial reviews

To be considered a bachelor's degree is required and an advanced degree preferred. You are to have 5- 8 years' experience working in clinical research or medical operations within the pharmaceutical or biotech industry. Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.). Compassionate Use or Managed Access programs preferred. We are seeking strong communication and presentation skills for senior management audiences.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$134,400.00 - $219,200.00

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