Regulatory Operations Specialist II

Overview:

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 Poland.

This position will support US FDA and Health Canada submissions and will require flexibility in work schedule, as needed, to accommodate deadlines for submissions that may occur during afternoon business hours in the US (Eastern Time).  We are looking for candidates who are open and able to work Polish evening hours (matching the US ET time zone) up to 2 days per week. Days are subject to change week to week based on US submission needs.

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.

• 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

• 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