Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring a Regulatory Operations Specialist II to join our team in the US.

This position will support US FDA and Health Canada submissions.

Our team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Rho, an award-winning, stable, full-service CRO known for its collaborative, dynamic culture based in the US, is quickly expanding their presence in Europe. Dokumeds is now part of Rho, and, as one thriving company, we will deliver global full-service clinical development services and unmatched customer support – worldwide.

Responsibilities

• Collaborates with sponsors and internal team members in the preparation, assembly, submission, and maintenance of regulatory submissions in compliance with applicable regulations and sponsor specifications
• Collaborates with sponsors and internal team members to avoid and address validation and technical specifications
• Publishes regulatory documents in accordance with eCTD standards and regulatory agency specifications
• As needed, assists with the formatting and quality control of a variety of regulatory documents.
• Supports day-to-day operations activities
• Assists with assigned project activities
• Attends internal training sessions for growth and development
• Exhibit Rho’s Core Values at all times
• Work in accordance with Rho’s Remote Hybrid Work Policy and attend meetings at any of Rho’s offices, sponsor site or client’s office as needed
• Provide excellent customer service to internal and external clients in a timely and professional manner
• Respond to email and other communication requests in a timely fashion using a variety of methods including but not limited to email, instant messaging and other communication tools
• Ability to maintain confidentiality
• Takes initiative to complete project-specific responsibilities with minimal supervision
• Other duties as assigned
  
  

Qualifications

• Bachelor’s degree in related field
• Minimum 3 years of prior experience
• 3 years of industry experience (in CRO or Pharmaceuticals)
• Experience with eCTD publishing tools
• Ability to perform report level publishing and submission publishing independently
• Experience in Life Sciences is preferred but not required, particularly familiarity with research processes and terminology
• Experience with eCTD publishing and document preparation as well as regulatory operations activities such as editorial quality review in general is a plus
• Advanced MS Word, Excel, and Adobe Acrobat (including applicable electronic publishing plug-ins)
• Knowledge of SharePoint is preferred
• Must be able to communicate effectively, positively, and professionally with internal and external clients, both written and verbal
• Strong organizational skills, including the ability to multi-task and balance individual and team responsibilities
  
  

A Few More Things To Know About Us

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $70,000 to $90,000 per year.

EOE. Veterans/Disabled