Medical Affairs Manager Jobs

Medical Affairs Director, Rare Disease — United States > Madison : 5505 Endeavor Ln. Apply via Workday.

Medical Director, Medical Affairs — . Apply via Workday.

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description We are seeking a Medical Strategy professional to join the Global Medical Strategy team for Lymphoma and Leukemia. This role partners closely with the Global Medical Lymphoma/Leukemia lead to support the development and execution of medical strategy across the product lifecycle, including marketed products and pipeline indications. The position collaborates cross‑functionally with internal partners and external experts to ensure the generation and communication of scientific evidence that supports optimal patient outcomes in hematologic malignancies. An exciting opportunity has arisen to join the Global Medical Strategy Team for Lymphoma and Leukemia (LL). In this role, the right candidate will receive a great opportunity to be part of one of the recent most impactful medical advancements in patient care and an opportunity to work towards better outcomes for patients with hematological malignancies. <p

Associate Director, Medical Affairs - Content Studio Technology Lead — 2 Locations. Apply via Workday.

Director, Medical Affairs Oncology, Strategic Evidence & Collaborations (SEC) — United States – Remote. Apply via Workday.

Job Description Job Title: Medical Reviewer Employment Type: Contract Location: Brazil Experience – 2 to 5 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centres and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Job Purpose and Summary: Join a mission-driven organization at a transformative moment in employer-sponsored health care. As Executive Medical Director, Clinical Business Solutions at Aetna, a CVS Health company, you will lead the clinical team that serves as the clinical voice to our Commercial plan sponsors, prospects, and their advisors, demonstrating how Aetna’s clinical capabilities reduce cost, improve population health, and strengthen the member and provider experience. Reporting directly to the Vice President, Chief Medical Officer, Commercial & Innovation, you will direct a national team of clinicians (MD, RN, NP) providing clinical support to Aetna’s National Accounts, Large Group, and Public & Labor businesses, in close partnership with Field and Account teams. You will lead and continuously improve the operations of the team to raise the level and quality of clinical support delivered to the Field, while sharing directly in its external work — including personally cultivating and holding relationships with key brokers, consultants, and plan sponsors. The role is deliberately bidirectional. You will bring the voice of the customer and the producer community back into the organization, partnering with Clinical Operations, Medical Affairs, Commercial Product, and others to ensure our clinical offerings reflect what the market requires. <p

Job Description Job Title: Senior Executive / Specialist - Case Processing E mployment Type: Contract Location: Brazil (Remote) A bout ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database. Experience in ARGUS database. Experience in rare disease portfolio. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (ICSR, Safety database etc.). Candidate Profile: Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements. Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream. Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point

Job Title Senior Clinical Development Scientist, Ultrasound &EI Job Description In this role, you have the opportunity to Be a member of the medical and clinical affairs team in Greater China. Medical and Clinical affairs team is an integral part of global Chief Medical Office. The Clinical Development Scientist is responsible for executing evidence-generation processes, clinical development and market access strategies for New Product Introduction (NPI) projects and post-market activities. The role is responsible for analyzing clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributes to the study designs. The role drafts comprehensive Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and regulatory submissions, ensuring accuracy and compliance with regulatory requirements. The role maintains data integrity and accuracy throughout studies and performs rigorous literature searches and critical reviews to support evidence-generation processes, providing insights for strategic decision-making. You are responsible for Assesses clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributing to the development and refinement of study designs as needed, working under direct supervision. Executes clinical development and market access strategies for assigned New Product Introduction (NPI) projects and post-market activities, integrating inputs from stakeholders such as Marketing/BU Claims, regional/market needs, Health Economics, Market Access, and Post Market Surveillance (PMS). Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing meticulous attention to detail and adherence to regulatory standards.<

Regulatory Affairs Specialist, Medical Device — Vietnam - Hanoi. Apply via Workday.

re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios Location / Ubicación: Ciudad de México, México Position Summary / Resumen del puesto: Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations. Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios. Key responsabilities / Responsabilidades principales: Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones). Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS). Apoyar en la interpretaci

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and s

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life JOB TITLE: シニア薬事スペシャリスト DEPARTMENT: 品質保証・薬事&#xff08;薬事Cardiovascular/DIBポートフォリオ&#xff09; REPORTING TO: 薬事マネジャー ********************************************************************************************** Main Mission of Job “Being a “bridge” to deliver “meaningful” medical device to Japanese patients” 日本の患者さんに価値のある医療機器を届ける架け橋となる Main Responsibilities 血管内治療機器に関連する薬事業務に従事いただきます。 新製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、米国本社およびマーケティング部門と協力して、薬事承認および保険に関する申請戦略および作業計画を立案する。 薬事申請戦略および作業計画に基づき、米国本社および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成して審査当局に提出し、承認取得する。 保険申請戦略に基づき、必要な申請書を作成し当局に提出する。区分C1またはC2申請を行う場合は、マーケティング部門、保険担当部門と協力して、国内外のエビデンスの収集、保険適用申請書の作成と提出、説明資料の作成、関連学会や行政当局との折衝を行う。 製品の流通に際し、モデル情報の登録や帳票類の整備等、付帯する薬事関連業務を行う。 米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。 国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。 業界活動を通じ、品目の基準作成、薬事関連、保険関連などにおいて、業界側の考えを行政に提案する。 Must Haves 学士&#xff08;&#xff14;年制理系大学卒&#xff09;以上又はそれに相当する学位 医療機器又は医薬品の薬事申請業務&#xff08;クラスⅣの医療機器の薬事申請経験があれば尚可&#xff09; 米国本社との情報交換及び技術英語読解に必要な英語能力

We anticipate the application window for this opening will close on - 29 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Supplier Quality function partners with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and critical suppliers to ensure the quality, compliance, and performance of externally manufactured products and components. This team works cross-functionally with Research & Development (R&D), Quality, Regulatory Affairs, and Operations to support product lifecycle activities, drive supplier performance improvements, and maintain compliance with applicable quality system and regulatory requirements. This position may be performed remotely anywhere within the United States. Travel up to 15% is required to support supplier audits, supplier performance reviews, business meetings, and cross-functional initiatives. The Senior Supplier Quality Engineer serves as the primary quality partner for strategic Contract Manufacturers and Original Equipment Manufacturers, ensuring supplier processes, products, and quality systems consistently meet Medtronic requirements. This role drives supplier quality performance, supports product and process changes, leads quality improvement initiatives, and provides technical quality guidance across supplier-related activities throughout the product lifecycle. Primary Responsi

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary: Ready to take your Medical Director career to the next level with a Fortune 6 company? Join Aetna, a CVS Health company, and make a meaningful impact on the health and well-being of Medicaid members across the country. Aetna operates Medicaid managed care plans in Arizona, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and West Virginia. We are seeking a Medical Director to join our centralized Medical Management team. This work-from-home position will primarily support Aetna Better Health of Louisiana , while also providing support across the other health plans as needed. In this role, you will partner with Medical Management staff to ensure timely, consistent, and clinically sound decisions for members and providers. Key responsibilities include: Utilization Management and medical necessity reviews Prior authorization and precertification determinations Concurrent review for inpatient and outpatient services Acute and post-acute care reviews Peer-to-peer consultations with treating providers Pharmacy reviews and first-level appeal determinations Collaboration with multidisciplinary clinical and operational teams The Medical Director also participates in a rotating on-c