Medical Affairs Operations Manager

This position is member of the clinical science & office of medical affairs team. This role is responsible for driving and managing medical affairs activities and logistics, assuring high quality and compliant processes and procedures.

This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.

Major Areas of Accountability

• Develop standard processes and procedures for medical affairs activities, including, but not limited to, dissemination of information, participation in complaint handling process and review, responding to scientific inquiries
• Development and implementation of a process for responding to field inquiries, customer inquiries and other relevant medical affairs related inquiries
• Establish and maintain standard operating procedures, policies, and work instructions for the medical affairs department, ensuring they are in compliance with external standards and oversight bodies
• Oversee development and updates to instructions for use master text, management of translations of medical affairs documents as required
• Establish calendar and project tracking for annual reports and updates of relevant clinical documents for relevant products
• Develop and maintain project trackers and metrics as requested
• Support activities to further medical affairs initiatives, education and collaboration across cross-functional partners
• Work in close partnership within US medical affairs team and other cross-functional team partners to strategically develop and manage US publication plan and conference plan.
• Work in close collaboration to plan, coordinate and execute all logistics related to congress planning
• Support material development and logistics for internal review process for all externally used field medical materials as well as internal training materials.
• Development and execution of communication tools for medical affairs activities
• Provide medical affairs support on project teams as applicable
• Participate in benefit / risk ratio assessment for vigilance and Risk Management Files
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other duties as assigned

Basic Qualifications

• 5+ years’ experience within clinical research and / or medical affairs activities, preferably with medical devices
• Bachelor’s degree (health science or biotech area). Advanced degree in the health sciences preferred (MS, PhD, PharmD, MD)
• Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
• Ability to travel 10-25%

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs.

Employing about 16,000 people and with products available in more than 143 countries, we are one of the world s leading medical device companies.

We are constantly growing our business and always looking for new ways to move forward we explore, learn and look for new ways of doing things.

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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