FremontRecruiter Since 2001
the smart solution for Fremont jobs

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

Keywords: Ardelyx, Fremont , Project Coordinator of Regulatory Affairs, Advertising and Promotion, Advertising , Fremont, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Advertising Jobs


Growth Marketing Manager
Description: Growth Marketing ManagerThis position is fully remote. Salary BOE plus bonus, benefits, and stock options.Unagi Scooters is a San Francisco based, VC-backed company which designs and manufacturesthe world's (more...)
Company: Unagi Scooters
Location: San Francisco
Posted on: 03/3/2021

Product Marketing Manager
Description: DescriptionFounded in 2013, Skedulo is a fast-growing SaaS company headquartered in San Francisco and with offices in Australia, Vietnam, and the United Kingdom. Here, we use the latest technologies and (more...)
Company: Skedulo
Location: San Francisco
Posted on: 03/3/2021

Influencer Marketing Strategist
Description: If you are a Influencer Marketing Strategist with Campaign Management experience, please read on br br We are a small start up with offices in San Francisco, New York and Los Angeles. Our platform (more...)
Company: Optello
Location: San Francisco
Posted on: 03/3/2021


Social Media Manager (Volunteer Role)
Description: The DoinGud community is the brainchild of Manuel Gonzalez Alzuru, who was infected with COVID-19 in the early days of the pandemic. Upon returning home to Barcelona, he found he was unable to get help (more...)
Company: DoinGud
Location: San Francisco
Posted on: 03/3/2021

Senior Manager, Consumer Growth Marketing (Performance Lead)
Description: We're looking for a deeply experienced and data driven performance marketer with strong knowledge of online/offline marketing/performance channels to help own our consumer growth strategy. br br About (more...)
Company: DoorDash
Location: San Francisco
Posted on: 03/3/2021

General Manager Global Operations, Marketing and Advertising Agency
Description: General Manager, Global Operations br br Our client, a growing global full service digital agency is looking to add a talented Operations lead to their team. This person should have solid operational (more...)
Company: ad+one
Location: San Francisco
Posted on: 03/3/2021

Public Relations Manager, Latin America
Description: Who We AreWe're a cast of characters working to shine a spotlight on anime. Crunchyroll is an international business focused on creating both online and offline experiences for fans through content licensed, (more...)
Company: Crunchyroll
Location: San Francisco
Posted on: 03/3/2021

Head of Public Relations
Description: Public Goods is a DTC e-commerce company, the digitally native, membership-driven, one-stop-shop that offers high-quality, sustainable essentials across grocery, household, and personal care. Public Goods' (more...)
Company: Public Goods
Location: San Francisco
Posted on: 03/3/2021

Associate Creative Director, Art
Description: About The TeamDoorDash's mission is to grow and empower local economies. By building intelligent, last-mile delivery technology for local cities, DoorDash connects people with the local businesses they (more...)
Company: DoorDash
Location: San Francisco
Posted on: 03/3/2021

User Experience Writer
Description: Position: UX--Writer - Content Designer--RemoteLocation:--Remote - any U.S. LocationTerm: 1-2 yearsOur financial services client is looking for UX Writer - Content Designers - They work closely with Product (more...)
Company: MATRIX Resources
Location: San Francisco
Posted on: 03/3/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Fremont RSS job feeds