Ardelyx, Inc. Waltham , MA 02154
Posted 4 weeks ago
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as early-stage pipeline candidates.
Description (Remote Role)
As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. This position requires a thorough understanding of pharmaceutical regulations, excellent project management skills, and the ability to lead and collaborate with cross-functional teams.
Key Responsibilities
Comprehends, manages, and executes the commercial Promotional Review Committee (PRC)/Medical, Legal, and Regulatory (MLR) review process, ensuring all tactical plans are implemented in compliance with the promotional guidelines and hold all stakeholders accountable by reinforcing the process
Work with Marketing/Commercial to coordinate and prioritize materials for Promotional Review Committee (PRC) review
Assist in organizing, scheduling, and hosting PRC meetings
Perform operational tasks such as annotating within the Veeva PromoMats system to accurately capture all changes
Perform final proofing of materials before proceeding to an approved status
Provides 1:1 refresher training to internal and external stakeholders on PRC Policy and Procedures and PromoMats system user configurations, and actively works with colleagues to improve and update training
Reviews Planning & Prioritization forecast trackers for all products and provides strategic guidance to Commercial and agency partners on submission timelines to meet critical business deadlines and launch initiatives. Challenges assumptions and help identify opportunities to optimize project execution
Extracts raw data from PromoMats and provides a full analysis of process metrics, promotional material usage and offers recommendations based on findings
Works with Commercial and external vendors to ensure inventory is managed and captured accurately within PromoMats and runs regular reports to cross-check with teams
Collaborates with Regulatory to manage the workflow for label updates and ensures materials are updated appropriately, reviewed, and approved before the go-dark date
Supports any technology implementations that improve or affect the PRC process
Develops and maintains strong working relationships with internal and external stakeholders
Tracks and test system configurations on an Ad Hoc basis
Designs and implements effective and efficient project management tools and resources
Oversee the preparation, submission, and tracking of regulatory documents to health authorities, ensuring accuracy, completeness, and timely submissions
Collaborate with cross-functional stakeholders including Commercial, R&D, and Quality.
Actively support any internal and external audits/assessments that may require access to regulatory records, information, or reports
Qualifications
Bachelor's degree in a scientific or regulatory-related field
2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations
Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Data Management
Ability to work cross-functionally and with all levels of the organization, including Senior Leadership
Experience with Veeva Vault digital asset management system a preferred
Experience with Microsoft Office and Adobe systems
Proven experience in leading and managing regulatory affairs operations teams.
Strong team player, a professional capable of working collaboratively and independently, with excellent verbal and written communication skills
Excellent project management and organizational skills
Effective communication and collaboration skills
Experience with regulatory submissions
Location
The anticipated annualized base pay range for this full-time position is $81,000-$99,122. 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.
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 living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Ardelyx, Inc.