200+ applicants

Company

Original Job Post

Ardelyx, Inc. · 3 days ago

Regulatory Affairs Operations Specialist, Ad/Promo

Waltham, MA

Full-time

Remote

Entry, Mid Level

$81K/yr - $99K/yr

2+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

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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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory affairsPharmaceutical industryBiotechnology industryRegulatory operationsRegulatory information managementDocument managementData managementMicrosoft officeAdobe systemsProject managementRegulatory submissionsProblem-solvingHard-workingTeam playerProfessionalCommunicationCollaborativeVeeva VaultDigital Asset Management

Required

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 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

Preferred

Experience with Veeva Vault digital asset management system

Benefits

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

At least 11 paid holidays

Company

Ardelyx, Inc.

Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.

Founded in 2007

Fremont, California, USA

201-500 employees

https://ardelyx.com/

H1B Sponsorship

Ardelyx, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (2)

2020 (1)