Medical Affairs Program Manager

Select how often (in days) to receive an alert:This position is a member of the Clinical Science & Office of Medical Affairs team. This role is responsible for driving and managing clinical documentation to support marketing and regulatory needs, supporting innovation and sustaining product activities, and providing clinical expertise as required. This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.They will do this by defining near, medium and long-term objectives covering a broad range of medical affairs activities, such as:Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical evidenceIdentifying external clinical opinions, perceptions and trends that influence Coloplast performance globally, and where warranted, develop appropriate mitigating strategiesExecuting the scientific agenda, by engaging researchers through Coloplast activities and grants and other evidence generation activitiesSupporting the development of any regulatory or quality associated documentationMajor Areas of AccountabilityServe as medical expert for relevant product(s) and associated clinical conditionsOversee the medical affairs strategy development and implementation for designated area(s)Support the required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and other relevant documentsSupport development and updates of Clinical Evaluation Reports (CERs) and associated documents as assigned (i.e. CER, PMCF, SSCP, PSUR, etc)Develop and deliver medical device technical documents supporting product launch and sustaining activitiesLeverage latest literature, regulations and guidance to build and execute on evidence strategiesDrive publications of data to ensure relevant content at medical congresses and at Coloplast events.Develop and deliver relevant medical device training documents (e.g. training decks, in-service scripts, eLearning tools, etc.) supporting product launch and sustaining activitiesSupports with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plan, etc.).Manage publication activities, as applicableDevelop/sustain knowledge in urology, including professional conference attendanceSupport Investigator Initiated Study Program (IISP) as assignedProcess and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.Support to medical marketing activities (KOL engagements, symposia, review/validation of communications)Ensure timelines and milestones are achieved for all initiatives. Communicate regularly with stakeholders on project progress and risks to achieving milestonesReceive, provide, and track status updates from necessary stakeholders of assigned projects, ensuring alignmentProvides medical expertise for novel ideas, questions and information requests related to Interventional Urology productsFacilitates medical advisory boards as applicableEnsures resources/time spent is in line with project prioritizationParticipate in benefit/risk ratio assessment for vigilance and Risk Management FilesConform with Coloplast Code of Conduct and all local Compliance StandardsConform with Coloplast Q/EHS PolicyOther duties as assignedAdditional ResponsibilitiesMaintains strong understanding of product knowledge, relevant anatomy, and accepted applications and uses associated with our productsDevelop mechanisms for monitoring project progress for timely intervention and problem solvingPresent to, and partner with, business leaders on the overall health of the portfolio, successes, and areas of opportunityMaintain awareness and understanding of the market and competitive spaceKnowledge, Skills, and Abilities:Strong ability to review and interpret scientific data and researchDemonstrated ability to work across functions to prioritize and drive strategic objectivesExcellent oral and written communication skillsExcellent project management and organizational skillsAn understanding of biostatistics and trial designHigh degree of initiative and self-motivation with a strong sense of accountabilityAbility to identify, analyze and solve problems with minimal direction and make decisions with confidenceAptitude to successfully prioritize and manage multiple tasks while adhering to deadlinesAdaptability to realign initiatives quickly to meet shifts in the marketBasic Qualifications5+ years’ experience within clinical research and/or medical affairs activities, preferably with medical devicesBachelor’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 regulationsAbility to travel - 20-30%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

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s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward

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we explore, learn and look for new ways of doing things.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.Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark

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