Clinical Document Control Specialist

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows we improve the quality of life of patients provide more effective treatment options for surgeons uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You:

The Clinical Document Control Specialist is responsible for managing organizing and maintaining clinical documentation to ensure compliance with regulatory requirements and internal quality standards. This role supports clinical research teams by overseeing document lifecycle processes facilitating audits and ensuring proper archiving and retrieval of essential documents related to clinical trials and post-market studies. This role reports into the Senior Director of Clinical Affairs.

What Your Day-To-Day Will Involve:

• Document Management:

Create organize and maintain clinical trial master files (TMFs) and other essential clinical documentation.

Ensure all clinical documents are complete accurate and compliant with Good Clinical Practice (GCP) and regulatory requirements (e.g. FDA ISO 14155 MDR).

Manage version control and track document revisions to ensure all stakeholders have access to the latest versions.

• Regulatory Compliance:

Ensure all clinical documents meet regulatory and quality standards for submission to governing bodies.

Support internal and external audits by providing organized comprehensive documentation.

• Process Oversight:

Develop implement and improve document control processes to enhance efficiency and accuracy.

Train clinical team members on document control procedures and best practices.

Archiving and Retrieval:

Oversee the archiving of clinical documents.

Ensure timely and efficient retrieval of documents for inspections audits or project needs.

• Software and System Management:

Maintain and manage electronic document management systems (EDMS) or clinical trial software tools when utilized.

Ensure system access controls and confidentiality of sensitive data.

The Qualifications We Need You to Possess

• Bachelor's degree in life sciences regulator affairs quality assurance or a related field.

• 2-5 years of experience in document control clinical research or regulatory compliance within the medical device or pharmaceutical industry.

• Knowledge of GCP FDA regulations (e.g. 21 CFR Part 11) EU MDR and ISO 14155 standards.

• Strong attention to detail and organizational skills.

• Proficiency in electronic document management systems and Microsoft Office Suite.

• Excellent written and verbal communication skills.

• Ability to work independently and manage multiple tasks simultaneously.

The Qualifications We Would Like You to Possess

• Certification in Clinical Research or Regulatory Affairs (e.g. ACRP RAPS).

• Familiarity with clinical trial management systems (CTMS).

For US-Based Candidates Only

Work Authorization Status: Citizen / Permanent Resident

For this role the anticipated base pay range is $85000-88000 per year.

Plus eligibility for an annual bonus and equity/RSUs.

Understanding PROCEPT's Culture

At PROCEPT we believe every person matters. Every employee every patient every caregiver. Because we are here to create a revolution and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do while also working together seamlessly for a common goal. At Procept curiosity ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building an immersion in Procept’s history jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry where our people managers across functions come together to exchange ideas and grow as both managers and learners in an environment that challenges supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept we push beyond just finding a work/life balance we strive to find a work/life blend a professional world that you are honored and impassioned to belong to one that you can proudly share with your family friends and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

BENEFITS OF WORKING AT PROCEPT!

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage wellness programs on-site gym a 401(k) plan with employer match short-term and long-term disability coverage basic life insurance wellbeing benefits flexible or paid time off paid parental leave paid holidays and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race color national origin religion gender gender identity sexual orientation disability genetic information pregnancy age or any other protected status set forth in federal state or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to job-related skills depth of experience relevant certifications and training and specific work location. Based on the factors above Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus equity and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for and ask you to maintain trained status for and comply with all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.