Description

The Medical/Clinical Affairs Associate will support the Vice President of Clinical Affairs by providing both strategic and operational assistance to advance the company’s clinical goals. This role demands strong organizational abilities, a blend of clinical, scientific and business acumen, and the capacity to collaborate effectively with both internal teams and external partners. This is a remote position; however, candidates must be willing to travel for hospital visits, clinical site support, professional conferences, industry trade shows, and periodically to the company’s office as needed.

•  Collaborate with KOLs and clinical experts to support the design, execution, and dissemination of clinical evidence generation initiatives such as case series, real-world data collection, and investigator-initiated studies.
  
  
• Support the management of daily communications with Key Opinion Leaders (KOLs), clinical advisors, and external collaborators to facilitate relationship-building, evidence development, and strategic alignment.
  
  
• Develop and deliver clinical and educational programming in collaboration with KOLs, including product training, webinars, speaker programs, advisory boards, and hands-on workshops.
  
  
• Represent the company as needed during hospital and customer visits, professional conferences, and industry trade shows to build and maintain strong relationships with clinicians and key opinion leaders, while supporting clinical programs. Proactively collect market insights and clinical feedback to inform the company’s clinical development and medical strategies.
  
  
• Build, update, and maintain the department dashboard, including KOL database, project plans, progress metrics, departmental KPIs, and quarterly departmental performance updates.
  
  
• Prepare and critically review internal project and regulatory documentation, including Standard Operating Procedures,
• Clinical Evaluation Reports, complaint reports, post-market surveillance documentation, risk management files, and other clinical materials.
  
  
• Conduct critical review of marketing and external-facing materials, ensuring scientific accuracy and compliance with regulatory standards, while providing daily clinical support to marketing and sales teams. 

 Participate effectively as an employee of Covalon:

• Report immediately to manager, any variances from the target completion date of the tasks, or that the tasks cannot be completed.
  
  
• Work effectively in collaboration with other members of the department, or with managers and staff across the organization with whom tasks must be completed.
  
  
• Work in a safe manner so as not to endanger individual health and safety, or the health and safety of others.
  
  
• Work to achieve assigned tasks within the standards required (quality, quantity, time and resources).
  
  
• Comply with all legal requirements, all corporate policies and procedures, and with generally accepted business and ethical practices.
  
  
• Perform other duties as assigned by immediate manager.

Education: 

• Bachelor’s degree in nursing (BSN) or higher is required.
  
  
• Advanced education (APRN, NP, PA) and certifications in Clinical Research, Medical Affairs, or a related discipline are considered strong assets. 

Knowledge/Experience/Skillsets: 

• Registered Nurse (RN) with a minimum of two years of bedside clinical experience in an acute care or hospital setting. Experience in the insertion and maintenance of IV catheters is an asset, along with knowledge of surgical environments and/or wound care practices.
  
  
• A solid foundation in the medical device industry, including familiarity with clinical operations and regulatory standards, is highly valued.
  
  
• Experience in clinical support, study coordination, and medical education in the medical device industry, with a strong track record of designing and delivering product training and scientific presentations to healthcare professionals.
  
  
• Demonstrated expertise in Key Opinion Leader (KOL) strategy development, engagement, and management to support clinical evidence generation and market access.
  
  
• Excellent written and verbal communication skills, with medical writing experience preparing clinical summaries, abstracts, manuscripts, clinical study reports, presentations, or educational materials for healthcare professionals.
  
  
• Experience collaborating with cross-functional teams including Regulatory Affairs, R&D, Marketing, and Quality to align clinical strategy with business objectives.
  
  
• Well-versed in clinical documentation, data collection, adverse event reporting, and synthesizing clinical evidence to support regulatory and commercial strategies.
  
  
• Ability to develop protocols, analyze and interpret clinical data to generate insights that support product development, regulatory submissions, and market positioning.
  
  
• Strong foundation in Good Clinical Practice (GCP), FDA, ISO, and other relevant regulatory and ethical frameworks (e.g., 
  
  
• AdvaMed Code of Ethics, FDA, Health Canada, or ISO 14155).
  
  
• Proficient in Microsoft Office Suite (Powerpoint, Word, Excel, etc.).

Attributes:

• Strategically minded with the ability to develop, execute, and adapt clinical and medical affairs strategies aligned with organizational goals and evolving market needs. 

• Superior written and oral communication skills, capable of conveying complex clinical and scientific information clearly and effectively to diverse audiences. 
• Demonstrates an open and thoughtful approach to the responsible use of AI and other digital tools to improve efficiency, support high-quality work, and accelerate execution.

• Demonstrated adaptability, critical thinking, and a commitment to continuous learning in a dynamic clinical environment. 

• Strong interpersonal skills with the ability to build and maintain credible and lasting relationships with clinicians, investigators, KOLs, and cross-functional partners. 

• Analytical and data-driven, skilled in interpreting clinical data and insights to inform strategic decisions and support evidence-based outcomes. 

• Highly organized and detail-oriented, capable of managing multiple projects, timelines, and priorities in a regulated and fast-paced environment.  

• Collaborative team player with a proactive, solution-oriented approach to challenges and stakeholder engagement. 

• High ethical standards and commitment to compliance, ensuring integrity and transparency in all activities. 

Located at one of Covalon’s global offices, or working remotely, this position requires the incumbent to spend 80-90% of the time at a workstation, the rest of the time in meetings and consultation sessions with staff, management and customers. Travel will be required as directed to attend on-site meetings, customer locations, trade shows, and conferences. On occasion, the incumbent will be required to have irregular hours.

The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.