[Hiring] Product Development Specialist @Merit Cro Inc
Apr 01, 2025 - Merit Cro Inc is hiring a remote Product Development Specialist. 💸 Salary: unspecified. 📍Location: USA, Canada.
Role Description
The Product Development Specialist will support the EXCELSIOR platform’s product development, focusing on gathering, documenting, and verifying requirements for the support of clinical trials. This role involves collaborating closely with subject matter experts (SMEs) to confirm that business and technical requirements are met and acting as the primary liaison between SMEs and the development team. The Specialist will be responsible for translating user stories and business needs into clear, actionable requirements for the development team. They will also ensure compliance with regulatory standards such as FDA 510(k), 21 CFR Part 11, and Good Clinical Practices (GCP).
- Extensively understand MERIT proprietary products and conduct of clinical trials in sufficient detail to manage tasks with Product Operations and Management (POM), development, and validation team members
- Comply fully with MERIT policies and Standard Operating Procedures (SOPs)
- Collaborate with stakeholders to gather business and technical requirements
- Ensure requirements are prioritized in collaboration with product operations and development teams
- Organize and Track EXCELSIOR development requests
- Collaborate directly with development team to communicate user stories and requirements
- Clarify ambiguities and ensure development stays aligned with project goals
- Write requirements in collaboration with SMEs, development and validation teams
- Guide audit trail requirements gathering to align with Good Documentation Practices (GDP)
- Assist with Research and Development projects
- Work closely with development project management to prioritize development efforts
- Provide training and guidance to POM personnel for Clinical trial configuration as new functionality is introduced
- Assist POM in troubleshooting and reporting of bugs/defects to development team
- Assist in permissions configurations related to new functionality in preparation for software updates
- Act as SME in areas where directly involved in requirements writing and implementation of new functionality
- Participate in continuous improvement initiatives to refine internal processes, improve product quality, and optimize user experience
- Comply fully with company policies and SOPs
- Other responsibilities may be assigned as required
Qualifications
- Minimum of a high school diploma
- A minimum of five (5) years of work experience in health related, biological science, computer science, data entry, customer service or business management field
- Strong interpersonal and organizational skills
- Excellent attention to detail
- Ability to follow direction, assess company needs and work independently
- Proficiency in Microsoft Office software
- Ability to troubleshoot new applications and learn company specific software
- Experience with clinical trial imaging software and/or familiarity with DICOM standards
- Ability to participate and contribute in a team environment
- Clear, concise, and effective oral and written communication
Requirements
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Benefits
- 401(k)
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
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| 📍 | Be aware of the location restriction for this remote position: USA, Canada |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
💸
unspecified
|
Remote
Location
USA, Canada
|
|
Job Type
full-time
|
Posted
Apr 01, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA, Canada |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
