Medical Affairs Specialist

Rhian_Convatec; London; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Medical Affairs Specialist to enhance the lives of patients through innovative medical solutions. This role involves coordinating clinical development and medical affairs activities, ensuring compliance while fostering strong relationships with clinical investigators. The ideal candidate will possess a Bachelor's degree in Nursing or Allied Health, with at least 3 years of relevant experience. You will thrive in a dynamic environment, contributing to new product development and providing medical expertise across various teams. Join a transformative journey that promises to elevate your career and make a significant impact in the medical field.

Qualifications

• Minimum 3 years experience in stoma/colorectal or urology care.
• Ability to work independently and in teams, embracing change.

Responsibilities

• Coordinate clinical development and medical affairs activities.
• Review and approve clinical documents and provide medical input.

Skills

Nursing/Allied Health

Clinical Research

Project Management

Communication Skills

Interpersonal Skills

Regulatory Knowledge

Problem Solving

Team Collaboration

Education

Bachelor's degree in Nursing/Allied Health

Equivalent Life Sciences degree

Job description

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, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more about Convatec, please visit http://www.convatecgroup.com

At ConvaTec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence.

Join us as a Medical Affairs Specialist, and you’ll do the same.

Our successful Medical Affairs Specialist OC/CC will co-ordinate clinical development and medical affairs 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. Additional activities may include supporting medical information requests, medical training, support to the local commercial business unit teams, support for organizing advisory boards, aligned with the Medical Affairs and Clinical Development Director OC/CC.

Duties and Responsibilities:

• Represent medical/clinical on core/project teams for new product development and change control including risk assessments and IFU development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, and product risk reviews.
• Review and approve 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.
• 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 activities including but not limited to country and site selection, 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/Allied Health or equivalent Life Sciences with at least 3 years post qualification experience in stoma/colorectal or urology care.
• 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.
• 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, 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 of 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 delay.
• 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 with occasional travel where needed for team meetings/events.

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.

This is stepping outside of your comfort zone.

This is work that’ll move you.