Medical Communications Manager

Location:                    London, UK

Reporting to:             Senior Director, Medical Communications

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England.

Job Summary

Reporting to the Senior Director, Medical Communications the Senior Manager, Medical Communications will be responsible for overseeing the processes for program-level planning and execution across medical communications, medical publications, and medical information activities for assigned gene therapy programs within the strategic framework set by the Global Medical Communications Leadership. The individual in this role will work in partnership with the broader Medical Affairs organisation, cross-functional partners, and external stakeholders, as appropriate, to support the development, and execution of Global Medical Communications and Publication Plans in alignment with program and organizational goals, and to ensure effective execution of medical information roles and responsibilities for supported clinical programs_._ The individual in this role will serve a critical role in the dissemination of Orchard-sponsored research and medical information, ensuring accuracy, high quality, and compliance. This position requires a professional with established personal and scientific credibility, self-awareness, and strong written and verbal communications skills, who works well in a collaborative, cross-functional environment that includes Clinical Development, Diagnostics, Pharmacovigilance, Patient Advocacy, Regulatory, Translational Research, Commercial, Corporate Communications and other functions and regional stakeholders within the broader organization.

Key Responsibilities

Medical Communications Planning and Execution

• Oversee the process for planning and implementation of the Global Medical Communications strategy across assigned investigational and approved gene therapy programs in alignment with program and organizational goals
• Translate complex clinical and scientific data into clear, balanced, and impactful deliverables for healthcare practitioners and other key stakeholders
• Lead the creation and review of medical communications content, including slide decks, infographics, FAQ documents, medical booth assets, ensuring all materials are regularly updated, accurate, and adhere to regulatory and compliance requirements

Medical Publications Planning and Execution

• Oversee the process for development and implementation of the Global Publications Plan across assigned investigational and approved gene therapy programs in alignment with program and organizational goals
• Oversee the planning and tactical execution of company-sponsored publication activities (i.e, abstracts, posters, oral presentations, manuscripts, and publications extenders, if applicable), including critical review of publications drafts, ensuring the development of high-quality, scientifically accurate, and timely publications
• Manage third-party publications agencies or medical writers
• Interface with external experts (i.e., clinical trial investigators, key opinion leaders, and other healthcare practitioners) and internal stakeholders for the planning, review, and approval of publications activities, including the management of Publication Steering Committees, if applicable
• Ensure all publications activities comply with Good Publication Practice (GPP) guidelines, ICMJE, and company policies and procedures
• Build and maintain productive working relationships with alliance partners and external collaborators to ensure alignment on publications priorities, timelines, and deliverables and contribute to overall partnership success through proactive collaboration
• Oversight of publications management system
• Participate in department initiatives and activities to optimize publications practices and processes and stay current on industry trends and standards related to scientific publications

Medical Information

• Management of Medical Inquiry systems, content, and responses, including

• Oversight of validated system for intake and documentation of medical inquiries

• Ensure effective inquiry intake, triage, timely responses, and documentation in alignment with regulatory requirements and company policies

• Partner with Pharmacovigilance to ensure appropriate adverse event and product complaint identification and reporting

• Partner with cross-functional colleagues to lead the creation and maintenance of standard response letters (SRLs), non-standard responses, and other medical information resources, ensuring timely updates based on new data, regulatory changes, and literature surveillance 

• Develop and execute medical Information booth design and serve as Orchard Medical Affairs staff presence at clinical and scientific congresses

• Oversee systems and processes for documenting and evaluating managed access requests, including pre-approval access (compassionate use) requests

·         Analyse Medical Information intake data to identify trends, insights, and education gaps, and share analytics reports with internal stakeholders

Requirements

Qualifications

Education / Key Competencies

• Advanced degree (required: MSc, desirable: PhD, PharmD, MD) in a life sciences discipline required.
• Proven and relevant experience in medical affairs, medical communications, or publications within biotech, pharma, or medical communications agencies
• Track record of overseeing medical communications and/or publication planning and execution in a collaborative, fast-paced environment
• Strong understanding of regulatory and compliance requirements (i.e., GPP, ICMJE)

·         Demonstrated project management and vendor oversight experience

·         Demonstrated stakeholder management, including success working collaboratively in cross-functional settings

·         Strong interpersonal skills including verbal and written communication and ability to establish and maintain a positive and efficient collaborative working relationships with internal stakeholders, including remote team members

·         Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes

·         Strong attention to detail and excellent organizational and documentation skills

·         Problem-solving mindset

• Understanding of activities related to the planning, conduct, and analysis of clinical trials

·         Familiarity with medical information systems and inquiry management platforms

·         General interest in a broad range of medical communications activities

·         Experience in rare diseases and/or gene therapies is a plus