Regulatory Associate Program Manager
Our client is looking for a highly qualified and skilled professional for the role of Regulatory Associate Program Manager in Princeton, New Jersey. We are looking for a Regulatory Associate Program Manager for an eight-month project (with the possibility of extension) who wants to be part of a great organizational culture, is organized and loves the industry.
- Responsible for controlling submission content, being accountable for the receipt and workflow completion of all submission components
- Staying abreast of regulatory requirements and guidelines, current trends, and medical practice in the field of dermatology and immunology, including intelligence on new technologies or treatment advances
- Serve as subject matter expert in the pharmaceutical industry code of professional conduct
- Work with the Operations Manager to develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals
- Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies
- Experience associated with managing or publishing of global regulatory submissions is required
- Bachelor’s Degree in a related field
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
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