Search for Regulatory Specialist roles in Boston, MA, with a focus on clinical research, 1-3 years of regulatory affairs experience, requiring a Bachelor's degree, and full-time positions.

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Regulatory Specialist

Boston, MA

Clinical Research

1-3 years

Bachelor

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The Regulatory Specialist role at Beth Israel Lahey Health is fundamentally concerned with ensuring regulatory compliance in clinical research settings. The primary responsibility revolves around preparing and submitting various applications, responding to IRB comments, and managing compliance for clinical studies. This role will demand a proactive approach, as the specialist must not only prepare documentation but also troubleshoot issues that may arise during the regulatory process. Successful candidates will face challenges such as meeting tight deadlines and navigating the complexities of FDA guidelines and IRB requirements. Key qualifications include a strong educational background in regulatory affairs, as well as hands-on experience in clinical trial regulatory compliance, which are essential for understanding and applying relevant regulations effectively. Furthermore, the ability to communicate clearly, both orally and in writing, is crucial as the role involves significant interaction with researchers and regulatory bodies. The successful candidate is expected to embody a problem-solving mindset, demonstrating autonomy in decision-making while collaborating effectively with team members to enhance operational efficiency. Achieving compliance and supporting the activation of clinical trials successfully would be indicative of high performance in this role within the first year.

Company Analysis:

Beth Israel Lahey Health occupies a vital and supportive role in the healthcare delivery landscape, providing essential services through a collaborative community of over 35,000 professionals dedicated to patient care. The organization is characterized by a mission-driven culture that places a strong emphasis on teamwork and patient safety, which aligns with the responsibilities of the Regulatory Specialist role. The company has a progressive stance towards innovation, as evidenced by its partnership with Lensa, a tech-driven recruitment platform that prioritizes matching candidates with job opportunities through advanced algorithms and assessments. This enhancement in operational efficiency showcases the organization’s commitment to improving the healthcare landscape, which can create ample opportunities for those in regulatory roles to influence clinical research positively. The Regulatory Specialist will likely work within a multi-disciplinary team structure, collaborating closely with investigators and regulatory bodies, ensuring that they have visibility with leadership through their critical contributions to compliance and protocol activation. As the healthcare industry continues to evolve, the role's alignment with strategic functions such as patient safety and regulatory adherence will be paramount for the organization's growth and integrity.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Tell me about a time when you had to handle multiple regulatory submissions. How did you prioritize your tasks?
Can you describe a situation where you encountered a significant compliance challenge? What was your approach to resolving it?
Discuss an experience where you worked as part of a team to improve operational processes in a regulatory or clinical setting.
How do you ensure accurate communication of complex regulatory information to team members or stakeholders?
What steps would you take to prepare for submitting an IND application to the FDA? What key elements would you prioritize?
Describe your experience with clinical trial regulatory documents. Which documents are you most familiar with?
How would you handle a situation where a clinical trial protocol deviates from approved regulations?
Imagine you encounter a concern raised by the IRB regarding a submitted application. How would you approach addressing their feedback?
Why are you interested in working at Beth Israel Lahey Health specifically, and how does your background align with our mission?
What do you know about our partnership with Lensa, and how do you think it impacts the regulatory landscape in our organization?
How do you stay current with changes in regulatory guidelines and compliance requirements?
What are some of the biggest challenges you foresee in the role of Regulatory Specialist?
In your opinion, what qualities are essential for fostering a culture of compliance and teamwork in a clinical research setting?
What questions do you have about the team structure I would be working with?
How does Beth Israel Lahey Health's mission resonate with you personally and professionally?

Job Details

Overview Company

Regulatory Specialist

Lensa

16 days ago

Highlight

OnsiteFull-time1-3 yearsEntry

Summary

Beth Israel Lahey Health is seeking a Regulatory Specialist to join their team in Boston, MA. The role involves supporting regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC).

About the Role

As a Regulatory Specialist, you will prepare and submit applications for clinical studies, respond to IRB comments, and assist in study activation. You will oversee reporting of adverse events, assist in IND applications to the FDA, and act as a liaison between the IRB and investigators. Additionally, you will help prepare and implement regulatory office SOPs.

About You

Required:

Bachelor's degree required; Master's degree preferred in Regulatory Affairs.
1-3 years related work experience required.
Good understanding of FDA, cooperative group, NCI, and OHRP regulatory guidelines.
Experience with computer systems, including web-based applications and Microsoft Office.

Preferred:

1-3 years of clinical trial regulatory affairs experience preferred.

Lensa

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With teams in multiple U.S. locations and a 60-strong crew of developers and data scientists at its R & D headquarters in Europe, Lensa is working every day to share its transformative career technology with the world.

Boston, MA