
OGT · Cambridge
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to delive...
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships
that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next
generation of precision medicines.
An opportunity has arisen in our Medical Affairs team for a Medical Affairs QC Analyst. This role offers a varied mix of hands‑on
laboratory work and quality-focused administrative responsibilities, supporting key FISH and NGS processing activities.
products and samples are handled correctly, and that all necessary records and quality data are maintained.
reagents, microscopes, equipment, and software.
implementation of CAPAs and improvements.
13485:2016, ISO 27001:2022, (EU) 2017/746 (IVDR), GCLP and Human Tissue Act (2004))
What we are looking for in you
Essential
of one-year laboratory experience
Desirable
Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice
period.
Please note that we will need to establish your right to work during the recruitment process.
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines. ** This position is a fixed-term contract, ending in December 2028 ** Our Medical Affairs Scientists are knowledgeable individuals who are passionate about ensuring that OGT’s products are safe, effective, and fit for purpose, thus allowing them to be available globally and state of the art. You will play an integral role in the delivery of internal and external analytical and clinical performance data for a range of OGT products. What you’ll be doing for us: To work as part of a team in executing tasks as directed, but not limited to, the following activities: * Contribute to the documentation and infrastructure of the department by overseeing the writing of internal and external protocols, study plans and reports * Participate in the design, implementation and delivery of any required studies * Identify and engage external laboratories, clinicians, and partners to obtain clinical performance data * Support and coordinate external studies, including collaboration, data sharing, and contracting activities * Collaborate with internal and external stakeholders to support project delivery * Manage and coordinate projects activities from initiation through to completion * Analyse and interpret data across diagnostic techniques and deliver scientific, clinical, and analytical reports in a timely manner * Ensure timely and accurate reporting of study results * Provide clinical/scientific input for product brochures, catalogues and other marketing materials when required * Contribute to the quality management system and infrastructure of the department by providing input into internal protocols and implementation of CAPAs, change controls and improvements * Support validation activities for team equipment and software, and support maintenance of risk management documentation in line with ISO 14971 * Provide training and support to medical affairs analysts and assistants as appropriate * Provision of analytical teaching within and outside of the medical affairs team as appropriate * Analysis of FFPE and haematological specimens using manual microscopes and automated software * Support karyotype analysis of G banding and reverse DAPI FISH images * To complete any other tasks as commensurate with the level and nature of the post as delegated by the line manager. What we are looking for in you Essential * A bachelor’s degree in molecular biology, biochemistry, genetics, biotechnology, or similar subject is required * Knowledge of FISH and/or cytogenetics techniques and their clinical applications * Understanding of clinical diagnostics, laboratory workflows, or molecular testing * Ability to engage confidently with external partners, including laboratories, clinicians, and collaborators * Proven ability to proactively drive activities forward * Experience drafting study protocols or similar technical/scientific documentation * Understanding of study design considerations, including objectives, endpoints and data requirements * Strong organisational and project coordination skills, managing activities from initiation through to completion * Ability to interpret clinical or diagnostic data, including comparison across different testing methodologies * Experience handling sensitive or clinical data, with an understanding of data quality and governance requirements * Excellent communication skills, both written and verbal. Desirable * Cytogenetics experience in an NHS laboratory or equivalent * Experience in data acquisition, clinical studies, or external collaborations * Experience setting up or supporting contracts, agreements, or study arrangements with external partners * Familiarity with disease areas, sample types, and appropriate testing approaches * Awareness of commercial or customer-facing environments, particularly in diagnostics or life sciences * Experience supporting clinical performance evaluations, validation, or regulatory activities * Experience in cytogenetics and or Karyotype analysis. In return you will receive: * Competitive salary * Pension Scheme (10% non-contributory) * Private Health Insurance * Private Dental Insurance * Group Income Protection * Group Life Assurance * 25 days holiday plus UK bank holidays * High Street Discount Scheme. Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period. Please note that we will need to establish your right to work during the recruitment process.
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The North America Head of Scientific Communications is a senior leadership role within NA Medical Affairs responsible for setting the strategic direction, oversight, and governance of scientific communications across the regional portfolio. This role ensures the delivery of high-quality, compliant, and impactful scientific communications that support evidence dissemination, medical education, and scientific exchange throughout the product lifecycle. The role provides leadership for regional publication strategy and execution, field medical resources, medical education content, digital scientific communications, congress activities, and regional medical review processes. The role leads and develops a high-performing scientific communications team and serves as a key strategic partner to Medical Affairs therapeutic area leaders, commercial team and cross-functional stakeholders. As a catalyst for innovation, the NA Head of Scientific Communications continuously evaluates emerging digital channels, data-driven insights, and evolving stakeholder engagement preferences to ensure Medical Affairs remains at the forefront of scientific exchange. This includes leveraging modern communication platforms and formats—including social media, podcasts, and other digital channels—to meet the evolving information needs of healthcare professionals, scientific experts, and key opinion leaders. Essential Functions: Future Pipeline Expansion & Capability Building * Proactively prepare NA Scientific Communications to support future pipeline expansion, including new therapeutic areas, indications, modalities, and lifecycle stages. * Anticipate scientific communications needs associated with pipeline progress and evolving portfolio complexity, including early asset planning, launch readiness, and post-launch evidence dissemination. * Design scalable scientific communications approaches, processes, and resourcing models that can flex with portfolio expansion. * Partner with Global Medical Affairs and Clinical Development to ensure early alignment of scientific narratives, data generation plans, and publication strategy for pipeline assets. * Identify capability gaps and lead continuous improvement initiatives across scientific communications, including talent development, vendor partnerships, and operational excellence. Strategic Leadership & Governance * Develop and own the regional scientific communications strategy across multiple products, aligned with global medical strategy, portfolio priorities, and North America Medical Affairs objectives. * Establish and maintain regional governance frameworks, standards, and best practices for scientific communications across channels and formats. * Serve as a senior scientific communications advisor to North America Medical Affairs leadership and therapeutic area leads. * Ensure compliance with internal SOPs, Good Publication Practice (GPP), ICMJE guidelines, and all applicable regulatory, legal, and compliance requirements. Publications & Evidence Dissemination * Oversee regional publication planning and execution, including abstracts, manuscripts, posters, oral presentations, and plain language summaries. * Ensure timely, high-quality execution of regional publication plans in collaboration with global partners, investigators, and external authors. * Provide strategic oversight of publication vendors and agencies, including scope, budgeting, and performance management. Scientific Content & Medical Materials * Lead development and lifecycle management of regional scientific narratives, lexicons, and key data-driven messages. * Oversee creation, approval, and maintenance of regional field medical materials, including slide decks, FAQs, disease education materials, and data summaries. * Ensure all materials are scientifically accurate, strategically aligned, audience-appropriate, and tailored to regional needs. Medical Education & Congress * Oversee scientific content for regional medical education, insight generation initiatives, advisory boards, and peer-to-peer scientific exchange. * Provide scientific communications leadership for regional congress strategy and execution, including content development, scientific booth materials, and symposia support. * Partner closely with Field Medical and Medical Education teams to align content with scientific objectives and stakeholder insights. Digital Scientific Communications * Provide strategic oversight of regional digital scientific assets, including modular and omnichannel-ready content, congress digital materials, and online educational resources. * Partner with digital and omnichannel teams to ensure scientific rigor, consistency, and effective data visualization across platforms. Medical Review & Compliance Oversight * Lead and oversee regional medical review processes to ensure efficient, compliant, and high-quality review of scientific communications materials. * Serve as a senior medical/scientific reviewer and escalation point for complex scientific, regulatory, or compliance-related issues. * Drive continuous improvement of review workflows and cross-functional collaboration. People Leadership & Talent Development * Lead, coach, and develop a team of scientific communications professionals, fostering a culture of scientific excellence, accountability, and collaboration. * Set clear objectives, provide ongoing performance feedback, and support professional development for direct reports. * Build and sustain a high-performing scientific communications function capable of supporting a growing and evolving portfolio. * Anticipate future portfolio and pipeline needs to inform thoughtful expansion of the scientific communications team over time. * Define future role profiles and succession plans to ensure the organization scales effectively as new assets and therapeutic areas are added to the portfolio. Decision-Making Authority * Accountable for regional scientific communications strategy, priorities, and execution across the North America portfolio. * Final scientific approval authority for regional scientific communications materials within established governance and SOPs. * Authority to manage external vendors and agency partners. * Escalation authority for complex scientific, compliance, or reputational risk issues related to scientific communications. Strategic Partnerships & Cross-Functional Leadership * Serve as a strategic partner to North America Medical Affairs Leadership, Therapeutic Area Heads, Field Medical, Global Medical Affairs, and Global Scientific Communications to ensure alignment of scientific communication strategies and execution. * Collaborate closely with Clinical Development, HEOR, Regulatory Affairs, Legal, Compliance, Commercial, Digital, Omnichannel, and Alliance partners to develop and deliver impactful, compliant scientific communications and medical education initiatives. * Represent North America Scientific Communications on cross-functional governance committees, leadership forums, and strategic initiatives, providing scientific communications expertise and influencing organizational priorities. * Foster strong alignment between regional and global scientific communications strategies, ensuring consistency, operational excellence, and effective dissemination of scientific evidence across the product lifecycle. * Build and maintain productive relationships with external stakeholders, including investigators, scientific authors, vendors, and agency partners, to support high-quality scientific communication deliverables. Subordinates: Medical Communication Directors (2) and Senior Manager, PRC/MRC Job Requirements: Education Advanced Scientific or Clinical Degree: An earned Ph.D., Pharm.D., or M.D. in a relevant life sciences, biomedical, or clinical discipline is strictly required. Experience * Minimum 12+ years of experience in Medical Affairs, or related roles within pharmaceutical or biotechnology organizations, at least 6 years in Scientific/Medical Communication. * Senior leadership experience managing scientific communications teams and leading complex, cross-functional, matrixed initiatives at regional or global scale. * Extensive oversight of end-to-end scientific communications activities, including publications, medical education, field medical materials, congress strategy, and digital scientific content. * Strong understanding of publication planning standards, medical governance, and regulatory and compliance requirements within a highly regulated environment. * Experience serving as a strategic partner to Medical Affairs leadership, with ability to influence cross-functional stakeholders and align scientific communication strategies with enterprise objectives. * Background contributing to transformation initiatives in Medical Affairs, including modernization of scientific communications and evolution toward digital and omnichannel engagement models. * History of building, leading, and developing high-performing, multidisciplinary teams, including mentorship of managers and senior scientific communications professionals. * Experience operating within global or regional matrix organizations, ensuring alignment between regional execution and global scientific communications strategy. Technical Skills & Competencies * Deep understanding of Medical Affairs operating models, governance structures, and the role of Medical Affairs across the product lifecycle, including its interface with Clinical Development, Regulatory, and Commercial functions. * Strong expertise in strategic planning, portfolio prioritization, and resource allocation within complex, global matrix organizations. * Comprehensive knowledge of Medical Affairs planning and execution, including scientific communications, publication planning, medical education, field medical strategy, evidence generation, and investigator-sponsored research activities. * Solid understanding of clinical development processes, regulatory requirements, compliance standards, and industry guidelines governing Medical Affairs operations. * Experience establishing and optimizing governance frameworks, operational processes, and performance metrics that enhance effectiveness, consistency, and scalability of Medical Affairs activities. * Ability to influence and align senior stakeholders across global and regional organizations without direct authority, driving consensus in highly matrixed environments. * Strong strategic acumen and business orientation, with the ability to translate enterprise priorities into actionable plans, clear governance structures, and measurable outcomes. * Advanced communication and executive presentation skills, with the ability to engage senior leadership and support informed, cross-functional decision-making. * Strong analytical capability, leveraging data, insights, and performance indicators to support prioritization, resource decisions, and continuous improvement. * Proficiency in business planning, portfolio tracking, and collaboration tools, with strong command of Microsoft Office applications (PowerPoint, Excel, and related tools). Non-Technical Skills Ability to thrive in a fast-paced environment while managing ambiguity effectively. Strong work ethics are required. Passion for personal learning and professional development. Cultural sensitivity and adaptability within multinational organizations. The anticipated salary for this position will be $250,000 to $286,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1
Description Evolus (Nasdaq:EOLS) is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. We are seeking an experienced and driven International Medical Affairs Manager to join our International Medical Affairs Team reporting to the Head of International Medical Affairs. The International Medical Affairs Manager supports international medical education initiatives, scientific programs, and operational activities across global markets. The role collaborates with healthcare professionals and cross-functional stakeholders to deliver high-quality educational programs, scientific resources, and medical insights that advance Medical Affairs objectives. The successful candidate combines scientific expertise with strong project management and operational execution skills. If you join our team, you will be working on some of the most exciting opportunities and challenges we face, with a team that values growth, recognition, and camaraderie. If you are looking for an opportunity to exhibit your knowledge and technical abilities in a unique environment, then look no further! In this role, you will be challenged to drive the success of Evolus in an effort to build a brand like no other. Essential duties and responsibilities where you'll make the biggest impact… Support the development and execution of international medical education initiatives aligned with Medical Affairs strategy and priorities Coordinate and manage medical education activities, including cadaver workshops, injection technique trainings, scientific meetings, and educational events Develop, review, and maintain scientific and clinical materials, including slide decks, educational content, FAQs, training resources, and anatomical education materials Support the identification, onboarding, development, and engagement of medical faculty members, trainers, key opinion leaders, and healthcare professionals participating in educational initiatives Serve as a scientific liaison across Medical Affairs, Marketing, Commercial, Regulatory, Compliance, and Legal functions to ensure alignment and appropriate scientific support Manage day-to-day Medical Affairs operational activities, including grants programs, educational events, vendor coordination, documentation management, and internal tracking systems Coordinate contracts, consulting agreements, purchase orders, invoices, and budget-related activities in collaboration with Finance, Compliance, Legal, and external partners Gather, analyze, and communicate medical insights from healthcare professionals, educational activities, advisory boards, and scientific meetings to support internal decision-making Monitor program performance metrics and evaluate educational outcomes to identify opportunities for continuous improvement Ensure all Medical Affairs activities are conducted in accordance with applicable regulations, company policies, and industry standards Maintain accurate records, databases, and documentation related to medical activities, educational programs, and scientific engagements Consistently demonstrate collaboration, accountability, and a commitment to scientific excellence while supporting evolving business needs and other duties as assigned Office Location – Milan, Italy (hybrid onsite Tuesday, Wednesday and Thursday) Up to 30% international travel Other duties as assigned Qualifications and Skills You’ll Bring to the Team… Advanced healthcare degree required (MD, PharmD, PhD, NP, or equivalent) 3+ years of experience in the pharmaceutical, medical device, biotechnology, or healthcare industry Experience supporting medical education programs and scientific engagement activities Demonstrated ability to develop and review scientific and educational materials Strong scientific literacy with the ability to translate complex clinical information into practical educational content Excellent communication and interpersonal skills with the ability to effectively engage cross-functional stakeholders and healthcare professionals Strong project management and organizational skills with the ability to manage multiple priorities simultaneously Experience working in international and cross-cultural environments Fluency in English Proficiency with Microsoft Office applications and standard business systems Preferred Qualifications… Experience within Medical Affairs. Experience in medical aesthetics, dermatology, neuromodulators, or related therapeutic areas Additional language proficiency beyond English Experience managing international educational programs and faculty development initiatives Experience working with grants, healthcare professional contracting, and compliance-related processes Compensation & Total Rewards Your actual base salary will be determined on a case-by-case basis and may vary based on a number of considerations including but not limited to role-relevant knowledge and skills, experience, education, geographic location, certifications, and more. We offer more than just a paycheck, and your base salary is just the start! Stay happy and healthy with our competitive suite of benefits to help you feel your best and be your best. You may also be eligible for new hire equity and long-term incentives in the form of RSUs, stock options, and/or discretionary bonuses. We offer mental health and wellbeing resources for you to develop skills to find your calm, boost your confidence, and show up as your best self in work and life. Travel or relax and come back feeling refreshed. Did we mention the holiday soft closure between the Christmas and New Years holidays? We have that, too, and the opportunity to join an organization where our values of Grit, Impact, Fun, and Transparency are displayed daily. Evolus takes pride in being a company on the forefront of innovation, while being committed to conducting its business with the highest degrees of integrity, professionalism, and social responsibility. We are also committed to complying with all laws and regulations that apply to our business. Employee welfare is no different. Here at Evolus, we don’t just work together, we’ve built a culture of inclusion! Because of this, you’ll find yourself immersed in an environment that not only promotes respect, collaboration and team building, but a community too. And that’s just the tip of the iceberg. Join our team and see for yourself! EOE M/F/D/V. For more information, please visit our website at www.evolus.com. #LI-FB1 #LI-HYBRID