Regulatory and Start Up Specialist

Job Overview

The Regulatory and Start Up Specialist position at Precision Medicine Group is designed for professionals in the clinical research domain, specifically focusing on regulatory affairs and clinical trial start-up. This role is crucial for ensuring site activation readiness within the assigned countries and sites, aiming for timely execution of trials while adhering to regulatory standards. Precision Medicine Group is a recognized Clinical Research Organization providing integrated solutions for precision medicine.

Key Responsibilities

The essential functions associated with this role include:

• Delivery of Site Activation Readiness: The candidate will be responsible for ensuring that all necessary steps for site activation are executed in a timely and high-quality manner. This includes foreseeing potential risks and developing strategies to mitigate them.
• Preparation of Clinical Trial Applications: A significant part of the role involves preparing Clinical Trial Application Forms and submission dossiers for various authorities such as Competent Authorities, Ethics Committees, and local bodies. This requires adhering closely to local regulations and timelines.
• Interaction with Authorities: The specialist will interact with relevant authorities and committees, handling responses to inquiries from them. Regular updates about the status of submissions need to be communicated to the Start-Up Lead and other project managers involved.
• Collaboration with Multifunctional Teams: The candidate will work closely with multiple departments including Feasibility, Clinical Operations, and Project Management, ensuring effective communication and project status updates.
• Documentation Management: The role involves maintaining accurate project files, regulatory intelligence tools, and ensuring audit readiness.
• Patient Information Materials: The specialist will customize Patient Information Sheets and Informed Consent Forms to ensure they meet country-specific requirements.
• Budget and Contract Negotiation: The specialist may be involved in negotiations regarding study budgets and the execution of contracts under the direction of the Site Contract Management department.

Required Skills

To qualify for the Regulatory and Start Up Specialist role at Precision Medicine Group, candidates must possess several key skills and qualifications, including:

• A Bachelor’s degree in life sciences or a related field, preferably in a scientific or healthcare discipline. A background as a Registered Nurse (RN) or a qualification in Pharmacy is highly advantageous.
• Demonstrated experience in a regulatory or start-up role, whether it be in a CRO, pharmaceutical, or biotech environment.
• Strong communication and organizational skills, essential for ensuring smooth interactions with multiple stakeholders.
• Fluency in English is crucial for effective communication.
• Familiarity with computerized information systems and the ability to use electronic tools, such as spreadsheets and word processing, is required.

Preferred Qualifications

Though not mandatory, the following attributes are viewed favorably:

• Experience in regulatory and site start-up processes, including feasibility studies and contract negotiations.
• Use of milestone tracking tools or systems to manage project timelines effectively.
• Advanced degrees in medical or life sciences (MD, PhD, PharmD) or certifications in Regulatory Affairs (RAC) are beneficial.

Salary Information

The salary for the Regulatory and Start Up Specialist position has not been disclosed in the provided text. However, candidates can expect compensation to align with industry standards for similar roles in Clinical Research Organizations. Typically, salaries in this field may vary based on experience, qualifications, and specific locations.

Company Overview

Precision Medicine Group is committed to advancing the science of precision medicine by integrating various solutions including clinical trial designs and operational excellence. The organization focuses on bringing passion for rare diseases and oncology while working across various therapeutic areas. As the company continues to grow, it is keen on hiring professionals who are aligned with their mission.

Job Location

The position is based in Poland, allowing candidates who are either local or international (able to work remotely) to apply, provided they meet the job's specific requirements.

Application Process

Application processes typically involve the submission of a resume and potential interview rounds. Candidates are encouraged to maintain communication with the HR team and report any suspicious activities related to job offers, ensuring a legitimate hiring process.

In conclusion, for candidates interested in contributing to clinical research in a regulatory capacity while working with a passionate team at Precision Medicine Group, this role presents a unique opportunity. Interested professionals should ensure they possess the required skills and prepare for an engaging selection process.

This job offer was originally published on himalayas.app