Project Coordinator of Regulatory Affairs, Advertising and Promotion

Company: Ardelyx
Location: Fremont
Posted on: February 22, 2021

Job Description:

Ardelyx is a publicly traded biotech company focused on improving the lives of patients by developing and commercializing first-in-class targeted therapies that advance patient care. Using our discovery model, Ardelyx scientists have characterized new biological mechanisms and pathways that have enabled us to develop a pipeline of drug candidates to manage complications related to kidney and cardiovascular diseases. Our lead candidate, tenapanor, is a first-in-class small molecule therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis. If approved, tenapanor could completely change the treatment paradigm in a disease state with significant unmet need. We are advancing the build of our commercial organization to be prepared for launch of tenapanor in mid-2021.


Project Coordinator of Regulatory Affairs, Advertising and Promotion Purpose of the role: The Project Coordinator of Regulatory Affairs, Advertising and Promotion will be responsible for providing organization and filing support activities to the Director of Regulatory Affairs, Advertising and Promotion for the company's commercial products. This role will work with the Promotion Review Committee and guide the reviewers as host of the scheduled meetings, tracking materials for review, capturing comments and resolving changes using the Veeva platform. The Project Coordinator will work closely with the Marketing team to prioritize critical materials and develop agendas for each meeting to review the materials requiring discussion and resolution. The Project Coordinator will work with Regulatory and Marketing to determine submission timelines and assist with the preparation of materials for submission to FDA. The Project Coordinator will need to ensure effective communication and constructive working relationships with cross-functional team members and internal/external collaborators. Responsibilities may also include supporting or leading other projects related aspects of material review (e.g., Medical Affairs materials and sales training).
Position Responsibilities:

• Work with Marketing team to coordinate and prioritize materials for review
• Host Review Committee meetings and act as organizer and comment resolution point person
• Support the preparation of submissions to FDA
• Evaluate potential problems and technical glitches while helping develop solutions
• Assist in the management of Review Committee goals and project schedules
• Coordinate team members to keep workflow on track
• Ensure all materials are current, properly maintained and electronically stored
• Direct project correspondence by preparing and reviewing project proposals, memos, meeting minutes and emails
• Communicate with internal and external parties to help identify and define requirements and objectives
• Collaborate cross-functionally with Regulatory, Medical, Legal, Marketing and Agencies
• Adhere to budget requirements by monitoring expenses and assessing needs
• Support the preparation of submissions to FDA
• Evaluate potential problems and technical glitches while helping develop solutions The above assignments are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required.
  
  Core Competencies, Knowledge and Skill Requirements:
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Communication & Interpersonal Skills
  • Experience with Veeva or similar EDMS program(s)
  • Excellent communication and interpersonal skills capable of maintaining strong relationships
  • Ability to effectively collaborate in a dynamic environment
  • Strong organizational and multi-tasking skills Position Requirements:
    • BA/BS Degree desirable, but not required
    • Experience: 5+ years of pharmaceutical industry experience, with at least 3 years of experience focused on project coordination activities for prescription drug products
    • Some understanding of US regulatory regulations/guidance for advertising/promotion and labeling are a plus
    • Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying issues and making recommendations to management, as appropriate
    • Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
    • Knowledge of FDA filings a plus As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients. It's the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines. We are different for good. Ardelyx, Inc. is an Equal Opportunity Employer You have been redirected to a Ardelyx job page

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