Clinical Affairs Scientist Jobs

As a Clinical Affairs Scientist, you'll champion clinical study design and collaborate with study partners and IVD manufacturers to support successful regulatory submissions. You'll develop clinical study protocols, take the lead on clinical and method comparison studies, meticulously monitor data and performance, and prepare comprehensive reports for regulatory filings.

You'll dive into strategizing, collaborating with teammates and clients, all with a singular mission: successful clinical trials that support regulatory submissions. Join us in revolutionizing healthcare!

Responsibilities:

• Monitor and analyze clinical study data and report on performance both internally and with study sponsors. Prepare study reports to support Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc.
• Prepare and present clinical study strategies and protocols for regulatory bodies including the US FDA
• Assist with Institutional Review Board (IRB) submissions
• Lead and Manage internal and external resources to support all aspects of clinical and method comparison studies in accordance with Good Clinical Practice
• Development of clinical study strategies and protocols to support the validation of new medical and in vitro diagnostic devices
• Implementation of regulatory and clinical processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures
• Assist clients in identifying and contracting with potential Clinical Trial Sites and/or Reference Laboratories
• Creation of Clinical and Analytical Study Protocols and supporting plans and procedures, including Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team
• Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies

About MDC

For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients worldwide. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local community’s health. Learn more at www.mdcassoc.com.

By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.

Qualifications

• Understanding of IRB guidelines and Common Rule
• Excellent organizational and problem-solving skills
• Ability to establish and maintain effective collaborative relationships with coworkers, managers and clients
• Knowledge of applicable protocol requirements as provided in company training
• Effective time management skills
• Strong written and verbal communication skills including good command of English language
• Ability to manage competing priorities without compromising quality
• Bachelor's degree in a health care or other scientific discipline or educational equivalent
• Knowledge of the European Commission Medical and In Vitro Diagnostic Device Regulations.
• Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint
• Understanding of U.S. Food and Drug Administration (FDA) laws and guidance
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and HIPAA guidelines
• Attention to detail and accuracy in work
• 5-10 years’ experience in a clinical environment or medical devices industry, with specific experience in in vitro diagnostic devices

Travel Requirements

10-15% estimated travel includes:

• Scientific, medical, and industry meetings and conferences
• International travel as needed
• Meetings with regulatory agencies
• Study sites and clinical study management

Reports To

Director of CRO Services

Location

In-Office (Beverly, Massachusetts)

Remote-eligible

Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the North Shore (Newburyport and Rockport lines).

Pay And Benefits

MDC Associates, Inc offers competitive salaries and benefits, including health/dental, HRA, and 401k with a match. We also support an engaging work environment that provides everyone with the opportunity and structure to learn and grow.

• Medical, Dental, and Vision Insurance
• 401(k) with Match Potential
• Short and Long-Term Disability
• Salary + Bonus
• Flexible Spending / Dependent Care Accounts
• Group and Voluntary Term Life Insurance
• Flexible Paid/Sick Time Policy

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