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Expanded Access Manager Jobs (NOW HIRING)

... expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered * General understanding of regulatory frameworks governing pre-approval and continued ...

Market Access Manager

Torrance, CA ยท On-site

$115K - $150K/yr

... global expansion. Responsibilities: Market Access Strategy * Develop a deep understanding of ... Prepare and manage licensing, authorization, and compliance submissions to national regulators and ...

... expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered * General understanding of regulatory frameworks governing pre-approval and continued ...

... expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered * General understanding of regulatory frameworks governing pre-approval and continued ...

Key Responsibilities Performance Management * Serve as a lead resource for Field Access Manager ... By joining our team, you will not only expand your own possibilities, but you will contribute to ...

Sr. Market Access Manager

Torrance, CA ยท On-site

$125K - $180K/yr

... global expansion. Responsibilities: Market Access Strategy * Develop a deep understanding of ... Prepare and manage licensing, authorization, and compliance submissions to national regulators and ...

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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 7, 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.
Zone Access Manager - Nephrology

Zone Access Manager - Nephrology

Ardelyx

Los Angeles, CA โ€ข On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 2 days ago


Job description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact โ€” both within our company and in the lives of patients we serve.

Position Summary:
The Zone Access Manager (ZAM), Market Access serves as a key customer-facing role on the Ardelyx Market Access Team. Zone Access Managers serve as a dedicated point of contact for Ardelyx Area Business Directors (ABDs) and Care Coordinators within a defined geography. This role functions as a critical liaison between ABDs, HUB resources, nephrology practices, and dialysis organizations to optimize patient access and prescription pull-through for Ardelyx therapies.
Responsibilities:
  • Provide case management support throughout the entire patient access journey in collaboration with internal stakeholders, third-party partners, and healthcare providers (HCPs)
  • Collaborate with Ardelyx Area Business Directors and Care Coordinators to identify key members of the patientโ€™s healthcare team responsible for guiding patients through the access process
  • Educate HCPs, dialysis organizations, and office staff on available patient assistance programs and the importance of their role in facilitating access to therapy for appropriate, eligible patients, including training on approved web-based provider tools
  • Serve as the payer access expert for the assigned geography, proactively communicating coverage updates and policy changes to internal and external stakeholders in a timely manner
  • Identify and communicate market access trends across local, regional, and national payers, partnering cross-functionally to enable appropriate patient access solutions
  • Maintain and expand knowledge of national, regional, local, and account-level market dynamics, including coverage policies and prior authorization requirements
  • Demonstrate agility in managing change and complexity by adapting to evolving payer policies, market dynamics, and patient access challenges
  • Maintain and grow knowledge of HUB and specialty pharmacy channels to enhance HCP support
  • Work collaboratively to share insights into customer needs, access barriers, and payer opportunities, providing access insights to field teams and home office partners as appropriate
  • Identify key customer insights through effective questioning, critical thinking, and problem-solving; analyze and disseminate data to relevant stakeholders
  • Partner with Ardelyx sales leadership and field sales teams to deliver best-in-class patient services
  • Execute all activities in accordance with Ardelyx values and in compliance with all ethical, legal, and regulatory standards
  • Conduct the majority of engagements virtually using a multichannel approach, with occasional in-person engagement as business needs require
Qualifications:
  • Bachelorโ€™s degree with 5+ years of field access or reimbursement management experience or equivalent experience, preferably within the biotechnology industry
  • Strong functional knowledge of specialty pharmacy and health insurance, including Medicare Part D, commercial, and Medicaid plans
  • Demonstrated understanding of insurance eligibility, benefit verification, prior authorization processes, reimbursement coverage, appeals, financial assistance programs, copay support, and bridge programs
  • Working knowledge of HCP office workflows, including patient flow, prescription flow, and clinic operations; experience with nephrology providers or products preferred
  • Excellent interpersonal, communication, and relationship-building skills with the ability to influence cross-functionally
  • Ability to do Access presentations using Ardelyx approved resources virtually or live as business need requires
  • Proven ability to work effectively under pressure in a fast-paced environment
  • Self-motivated with a high degree of initiative, accountability, and attention to detail
  • Strong verbal and written communication skills
  • Comfort working in a โ€œroll-up-the-sleevesโ€ environment typical of a growing biotechnology company
  • Proficiency in Microsoft Office, including Excel
  • Experience with data visualization tools such as Tableau or Power BI preferred
  • Willingness to travel approximately up to 30%
The anticipated annualized base pay range for this full-time position is $131,000-$160,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.ย ย ย ย ย 
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Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),ย life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.ย 
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Ardelyx is an equal opportunity employer.