Senior Medical Information Officer
hace 12 días
Egham
Senior Medical Information Officer The Senior Medical Information Officer provides critical support to the wider Medical Department and is responsible for ensuring the delivery of high-quality and compliant MI to healthcare professionals, members of the public, and internal stakeholders. The role serves as a subject-matter expert within the MI function and plays a critical part in supporting accurate, effective, and ethical use of the company’s products, supporting the Marketing Authorisation Holder’s responsibilities. The incumbent will provide clear recommendations and solutions to problems and will support and mentor Officer(s). If you are keen to join a patient centric, high-growth company, then read on and apply today! What You Will Do Expert Response Development & Medical Content Management • Serve as the primary expert responsible for creating, reviewing, and maintaining timely high-quality, evidence-based, balanced, non-promotional MI responses, standard response documents, FAQs, and scientific materials in line with best practices and scientific developments across the product portfolio., • Manage and respond to high-complexity and/or escalated MI enquiries providing clear and accurate responses in accordance with applicable regulations and timelines, • Support MI colleagues by reviewing their responses and advising on complex case handling. Cross-Functional Medical Expertise • Act as a key MI representative in cross-functional teams (Medical Affairs, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Commercial)., • Provide scientific insights and ensure MI considerations are included in product launches, lifecycle management, and communication strategies., • Collaborate with wider Medical team to align key scientific messages and literature monitoring activities., • Collaborate with Regulatory Affairs to maintain product Information including updates to e.g. SmPC/PIL/Standard Responses., • Forward spontaneous Individual Case Safety Reports (ICSRs) to the PV vendor in accordance with the company’s current MI SOPs., • Collaborate with the QPPV, Medical Advisor and other Subject Matter Experts on various aspects of Pharmacovigilance upon request., • Support in reviewing and processing of certificates of analysis for received product batches., • Contribute to the documentation needed for:, • Monthly reconciliation of MI/PV/PQC to check every patient safety-related MI/PQC case has been escalated to assure PV Compliance, • Pharmacovigilance data and other relevant statistics for the compiling of compliance reports as needed Compliance, Governance & Quality Standards • Ensure all MI processes comply with local and international regulatory guidelines (e.g. MHRA, ABPI, EFPIA, local codes of practice, etc.)., • Contribute to audits and inspections, supporting documentation and process improvements, participating in relevant processes as required., • Lead or support the creation and updating of SOPs, work instructions, and quality standards for the MI service to ensure compliance and inspection readiness. Data Insights & Medical Intelligence • Analyse enquiry trends to provide actionable insights to Medical Affairs, Pharmacovigilance, and Regulatory Affairs colleagues., • In collaboration with Pharmacovigilance identify potential safety signals, knowledge gaps, or educational needs based on enquiry patterns., • Contribute to the development of medical strategies based on scientific and customer insights. Coaching & Mentorship • Provide technical guidance, training, and informal mentorship to MI Officer(s)., • Support onboarding of new hires and contribute to capability building within the department. What We Do Essential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations. Everything at Essential Pharma is driven by the fact that every patient matters. We are focussed on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 70+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland. We are an international business, with a growing product portfolio that reaches patients in approximately 70 countries. We cover multiple therapy areas with a particular focus on rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti-GD2 antibody for the treatment of high-risk neuroblastoma. We have a proven track record of acquiring, investing in and commercialising treatments. What You Will Bring Qualifications • Strong scientific background (typically life sciences degree; advanced degree preferred). Experience • Demonstrated experience in previous MI role(s) required., • Possesses excellent verbal and written communication skills with the ability to translate complex scientific information into clear, accessible responses., • Must be fluent in English (additional languages e.g. French, Spanish, German ideal)., • Working knowledge of industry codes of practice ideal. Core Competencies • Deep understanding of relevant therapy areas and product portfolios., • High attention to detail and strong commitment to accuracy and compliance., • Experience navigating and applying regulatory and industry codes of practice., • Ability to work cross-functionally and influence without authority., • Strong analytical and problem-solving skills, particularly in handling complex enquiries., • Proven ability to prioritise work to meet required deadlines., • Possesses a can-do attitude and committed to achieving success without compromising quality of work. What We Offer • Competitive salary, • We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview, • £150 towards your home office, • Healthcare, • Pension – you contribute 5% and we offer 5%., • Life Insurance – lump sum (tax free) death benefit of 4 x basic salary., • Enhanced family leave, • Enhanced sick pay, • 25 days annual leave, • Discretionary annual performance bonus What To Expect • At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us, • Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious, • This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success, • We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives, • We have an unwavering dedication to employee growth and development
