This posting is for a senior level position within a fresh and exciting startup. Cite Medical is a relatively new startup (3 years) that’s changing the way device manufacturers approach their Clinical Evaluation. Through a highly focused team and proprietary software platform, CiteMed can offer a depth of service that traditional ‘consulting firms’ can’t match.
Working with us will bring you into a high paced and autonomous environment where creativity and innovation are valued, not stifled. You will have a significant amount of freedom to work with the team and craft solutions for our clients. Additionally, you will have substantial input in the new products and offerings CiteMed is continuously building.
Your day-to-day responsibilities:
- Oversee the work output of other RA professionals and medical writing staff to complete a mix of SLRs, CERs, and PMS’s tasks in compliance with the EU MDR regulation.
- Assesses on an ongoing basis the quality, scientific validity, and audit-readiness of Clinical Evaluation Documentation.
- Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
- Plan and implement strategic technical growth programs and assess issues or risks with current systems.
- Participate in cross functional team meetings
- Attend calls and communicate with clients on technical feedback
- Attend calls with prospective clients to assess their needs and prepare recommendations/ proposals
- In addition to the above responsibilities, employee is required to contribute and perform other reasonably assigned tasks as needed.
Qualifications and Skills
- Bachelor’s degree (minimum) or advanced degree (preferred).
- A minimum of 7 years of experience in functions such as clinical, regulatory, medical affairs, quality, research, and medical safety where scientific/medical writing was required.
- Experience overseeing the writing of SLRs, CERs and PMS’s in a wide variety of medical device classifications
- Solid understanding of MEDDEV and EU MDR regulations.
- Ability to critically analyze and interpret scientific data (clinical and preclinical).
- Experience in managing contract resources and/or vendors.
- Have experience setting up MDR processes that integrate regulatory requirements and deliverables into businesses
- Have experience describing MDR services, experiences, and process to potential clients
- Self-motivated, with initiative and the ability to take ownership of and follow through with assigned tasks
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- Strong team player and work ethic.