Clinical Specialist, Infusion Care

2 weeks ago

London, UK, United Kingdom Convatec Full time

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, and a promise to be forever caring, our products and services are available in over 100 countries. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. The company is a constituent of the FTSE 100 Index (LSE: CTEC) and in 2024 revenues were over $2 billion.

About the role:

Our successful Medical Affairs Specialist, Infusion Care will guide clinical development activities on a project basis. This may include medical and clinical representation on New Product Development (NPD) Core Teams, Medical/Clinical input and expertise will also be provided for product change control activities, risk management activities (e.g., Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation, participating in project teams, reviewing Advertising and Promotional Materials from a Medical perspective and providing ad hoc medical advice to support other functions.

This role involves substantial review and analysis of technical documentation, requiring strong attention to detail and the ability to process complex medical device documentation efficiently in a remote work setting. Additional activities may include supporting medical information requests, medical training, support to the local commercial business unit teams, and support for organizing advisory boards, aligned with the Senior Director for Medical Affairs.

Duties and Responsibilities:

• Represent medical/clinical on core/project teams for new product development and change control including risk assessments and IFU (Instructions for Use) development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, and product risk reviews.

• Provide detailed review, analysis, and approval of documents from a medical perspective which include, but are not limited to: Clinical Research Protocols, Clinical Study Reports, and Clinical Evaluation Reports

• Provide medical input into Health Hazard analyses.

• Prepare and review technical documentation for regulatory submissions.

• Provide medical review support for Medical/Regulatory/Legal (MRL) approval for advertising and promotional material. Working closely with core/project team members to ensure claims and intended use are accurately represented.

• Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required.

• Consulted for input on the following activities including but not limited to country and site selection, and investigator meetings for clinical studies.

• Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management, and Marketing to ensure timely completion of medical affairs documents for Regulatory filings and medical responses to health authorities.

• Represents Convatec and provides medical expertise to relevant teams and External Collaborations: medical information, medical training

• Represent the organization in scientific and professional meetings where appropriate

Skills & Experience:

• Minimum of a bachelor’s degree in Nursing / Medical Degree / Allied Health or equivalent Life Sciences Degree with at least 1 year post-qualification experience in diabetes management and/or infusion care.

• Previous experience in medical device or pharmaceutical industry would be an advantage.

• Works both as a team member and independently, engages and supports other members of the team, and willingly accepts support when required. Is able to make decisions, in consultation, if required, and accept accountability.

• Strong aptitude for detail-oriented document review and technical writing

• Proven ability to manage multiple documentation projects while maintaining quality and meeting deadlines

• Willingly embraces change and the need to adapt to new circumstances. Takes an innovative approach while maintaining compliance.

• Can establish strong working relationships with clinical Investigators and key opinion leaders.

• Shows consistency among principles, values, and behaviours.

• Seeks and welcomes feedback, responds to coaching, and takes action to change.

• Effective use of oral and written communication skills to influence, inform, or guide others.

• Understanding of the medical device industry and the pre-clinical, clinical, marketing, and regulatory components.

• A proven ability to deliver results according to timelines. Anticipates problems and creates solutions to minimize potential delays.

• Solid understanding of project planning and project management methods and the ability to apply them.

• Great communication and interpersonal skills

Working Conditions

This role will predominantly be working from home, requiring self-motivation and the ability to maintain productivity while reviewing technical documentation independently. Occasional travel is needed for team meetings/events.

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