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  • GRA Device Associate

    Sanofi Us 4.3company rating

    Sanofi Us job in Cambridge, MA

    Job Title: GRA Device Associate About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others. As GRA Device Associate in the GRA Device Digital and Diagnostic team you'll contribute to global regulatory strategies for in-vitro diagnostic technologies, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide. The GRA Device Associate role offers the opportunity to support a wide range of diagnostics, including diagnostics used in medicinal product clinical trials, diagnostic reagents, and companion and complimentary diagnostics. Working at the intersection of science and compliance, you'll propose device strategies, conduct risk assessments, and interact with regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends-all contributing directly to bringing innovative therapies to patients worldwide. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people's lives. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Partner with the Device Regulatory Lead on assigned projects Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams. Contribute to and execute innovative and sustainable medical device regulatory strategies covering IVDs elements Contribute to device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions Identifies IVD regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes. Prepare and review design control deliverables. Contribute to product development and lifecycle management planning. Provide regulatory impact assessments for proposed product changes May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management. Contribute to internal regulatory processes and procedures for IVD About You Experience: 6+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 3+ years of relevant IVD regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions. Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to global IVD regulations (US FDA IDE/PMA, EU IVDR), technical documentation, ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies. Ability to synthesize and critically analyze data from multiple sources. Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Device, Manufacturing, and Quality teams. Demonstrates business acumen, strong leadership, influencing and persuasive negotiation skills Soft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies Education: Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred. Communication: Strong written and verbal communication and influencing skills, with fluency in English. Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach. Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy. Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration. Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your expertise. Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective. Enjoy a supportive R&D environment that values work-life balance, offering flexible working options (60% on-site) and comprehensive well-being programs. Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $122,250.00 - $176,583.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $122.3k-176.6k yearly Auto-Apply 60d+ ago
  • Transformation Leader - External Manufacturing - Biologics

    Sanofi 4.3company rating

    Sanofi job in Cambridge, MA

    Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. This is a hybrid role - 3 days a week onsite - required. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Support Transformation Delivery * Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. * Localize change strategies to fit the GBU context, culture, and priorities. * Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement * Ensure employees and managers understand the why, what, and how of transformation initiatives. * Develop and execute communication and training plans to maximize adoption. * Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support * Build strong relationships with GBU leaders to support them as change sponsors. * Provide coaching and guidance to managers and teams to reinforce change behaviors. * Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting * Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. * Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. * Capture lessons learned to continuously improve change implementation in the GBU. About You * Bachelor's degree in Business, Human Resources, Organizational Development, or related field. * 5+ years of experience in change management or organizational transformation. * Strong knowledge of CMO/CDMO manufacturing - Required. * Strong knowledge of change management frameworks * Demonstrated ability to work in complex, matrixed organizations. * Excellent communication, facilitation, and interpersonal skills. * Proven track record in supporting digital, operational, or organizational transformation programs. * Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy * Strategic thinking: Ability to see the "big picture" and anticipate trends * Organizational alignment: Connect transformation to business objectives Change Management * Change management: Master methodologies * Resistance management: Identify and address barriers to change * Change communication: Adapt messages to different audiences Operational Competencies * Project/Program Management * Business acumen with ability to translate transformation into operational impact. * Problem-solving and analytical thinking. * Process optimization: Identify and implement improvements * Digital literacy: Understand emerging technologies (AI, automation, cloud) * Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence * Cross-functional work: Orchestrate multi-functional teams * Inspirational leadership: Mobilize and engage teams * Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. * Emotional intelligence: Understand and manage emotions during change change * Negotiation: Find compromises and create consensus Soft Skills * Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) * Empathy: Understand the human impact of change * Resilience and adaptability in dynamic environments. Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $147k-212.3k yearly Auto-Apply 11d ago
  • Advisor, guide-RNA Process Development

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organizational Overview Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs - VERVE-101, VERVE-102, and VERVE-201 - target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. Position Summary: We are seeking an experienced process chemist to join the guide-RNA process development team. You will be joining a team that is heavily focused on clinical manufacturing process development. This is primarily a lab-based role supporting guide-RNA drug substance process development for programs in clinical development. The role will also contribute to the development of guide-RNA manufacturing platform technologies in a highly collaborative effort with process and analytical chemistry teams. Responsibilities: Design and execute solid-phase synthesis and purification experiments to support process development and scale-up of oligonucleotide drug substance manufacturing Lead guide-RNA process development efforts by identifying areas of continuous improvement through literature and state-of-art practices and applying these learnings to Verve's gRNA process development projects. Collaborate cross-functionally with process and analytical teams to progress process and manufacturing technology development projects Review and provide technical feedback on internal and external collaborators experimental designs and results Participate actively in technical discussions and meetings, proactively communicate technical findings and results to stakeholders, train and support teammates as needed Partner closely with members of facilities, lab operations, and safety to maintain the highest level of safety standards within the lab Keep an updated lab notebook, order materials, maintain lab equipment, and support equipment troubleshooting as needed Basic Requirements: PhD degree in a relevant scientific discipline with 1-2+ years of industry experience (synthesis, oligonucleotide development, solid phase synthesis, CMC) or MS degree with 6+ years of relevant industry experience (synthesis, oligonucleotide development, solid phase synthesis, CMC) Experience designing and troubleshooting oligonucleotide solid phase synthesis studies. Strong preference for candidates who have experience with guide-RNA or longmer synthesis development backgrounds. Experience with oligonucleotide manufacturing processes and equipment including solid phase synthesis (Cytiva OligoSynt or OP100), cleavage and deprotection, chromatography (Akta), TFF, sterile filtration, single-use technology, and sterile/aseptic processing preferred Background in oligonucleotide process development, scale-up, and GMP manufacturing Strong communication skills (oral and written) and the ability to thrive in a team and goal driven environment Additional Skills/Preferences: Background in CRISPR guide RNA development strongly preferred Use of strong interpersonal skills for collaboration Ability to prioritize multiple activities and handle ambiguity Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $138,000 - $224,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $138k-224.4k yearly Auto-Apply 4d ago
  • Director/Senior Director, CMC, Drug Product Development

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Job Summary The Director/Senior Director, CMC, Drug Product Development will lead formulation development activities across multiple dosage forms and therapeutic modalities, with a focus on developing and incorporating digital solutions and tools into drug product workflows. The ideal candidate will bring expertise in both parenteral and solid oral dosage forms, combined with emerging capabilities in computational and AI-driven formulation approaches. Success in this role requires cross-function collaboration and leadership as well as a strategic vision for how technology can be leveraged to transform traditional drug development activities. Key Responsibilities Formulation Development * Lead formulation design, development and external manufacturing for both parenteral (IV, SC, IM) and solid oral (tablets, capsules) drug products across diverse therapeutic programs and modalities * Develop robust formulation strategies that address in vivo performance, stability, bioavailability, manufacturability, and patient-centric considerations * Manage a network of external providers (CROs, CDMOs) with capabilities in drug product development and manufacturing * Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and manufacturing * Support regulatory interactions and respond to health authority questions * Ensure compliance with cGMP standards and ICH guidelines Digital Solution Development * Lead the development, testing and implementation of digital solutions related to drug product development * Partner with IT and other internal drug product subject matter experts to translate drug product workflows into requirements that can be incorporated into technology solutions * Lead the evaluation of in silico modeling tools and AI/ML platforms that predict formulation performance and accelerate development timelines * Continuously monitor the industry trends, competitive landscape and emerging technologies to identify future tools and technology platforms of interest Minimum Requirements * Education: PhD in Pharmaceutical Science or related field (Chemistry, Chemical Engineering, Pharmacy) * 8+ years of pharmaceutical industry experience * 3+ years of prior experience with application of in silico tools or AI/ML solutions in drug product development Additional Skills/Preferences * Experience working with multiple therapeutic modalities (small molecules, biologics, peptides, oligonucleotides) * Experience with both parenteral and solid oral formulations * Knowledge of emerging modalities including cell & gene therapy, RNA-based medicines * Strong analytical and problem-solving skills * Experience working with biotechs/emerging companies and/or early-stage development programs where speed to clinic is a critical success factor * Demonstrated ability to operate effectively in fast-paced environments where rapid decision-making and pragmatic problem-solving are essential to maintain program momentum * Track record of supporting multiple concurrent programs with varying levels of technical maturity, demonstrating agility in shifting priorities and creative approaches to address emerging challenges Additional Information * Remote options may be considered based on business needs * Travel up to 10% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $148.5k-257.4k yearly Auto-Apply 6d ago
  • ADME Project Leadership for Genetic Medicines

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Our diverse ADME team is seeking a dedicated scientist with an interest in the discovery and clinical development of genetic medicines, including si RNAs, ASOs, mRNAs, gene editing, and gene therapy. We are committed to advancing scientific boundaries to develop transformative therapeutics that address the underlying causes of diseases across a wide range of therapeutic areas. Applicants with strong problem-solving abilities and innovative thinking are encouraged to apply to join our team at the expanding Boston campus. Lilly's agile ADME team collaborates closely with biologists, chemists, engineers, and various other R&D functions to deliver novel genetic medicines to patients. Team members support each other through shared learning and collective responsibility for all stages of the discovery and development process for next-generation genetic therapies. We strive to foster professional growth while advancing science to provide safe and effective new treatments to patients. Prospective candidates who are motivated, collaborative scientists interested in spearheading innovation in genetic medicine therapies are invited to connect with us and contribute to improving patient outcomes globally. A high-quality candidate will demonstrate the following: High learning agility and a keen ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles - especially as they relate to novel genetic medicine therapeutic modalities Understanding of pharmaceutical regulatory guidance and expectations Agile interrogation of diverse data (e.g., in silico, in vitro, in vivo) to interpret complex data sets and to derive mechanistic understanding of drug action and ADME/DMPK characteristics Lilly seeks a skilled ADME / DMPK scientist who will: Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies. Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities Build relationships through coaching and mentorship with fellow scientists at all levels Possess excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams ' Basic Requirements: Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field Zero to five years of experience as a scientist in a pharmaceutical and/or biotechnology company Additional Skills/Preferences: Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics Experience with PK/PD modeling and simulation Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology Additional Information: This is a full-time position located in Boston, MA. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $156,750 - $250,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $156.8k-250.8k yearly Auto-Apply 45d ago
  • Director, Safety Scientist

    Astrazeneca 4.6company rating

    Boston, MA job

    The Director, Safety Scientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework. You will be responsible for: Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following: Proven skill set for strategic leadership in a cross functional matrix Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications Co-lead activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation Leading activities to identify and address process gaps Responsible for vendor management and training including budgets Responsible for overall project distribution across therapeutic area As needed represent GPS in global program teams and associated cross functional teams and/or projects Proactively provide guidance and educational training to GPS therapeutic teams Participate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products You will have: Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry Knowledge and understanding of US and EU safety regulations pre- and post- marketing Experience with Risk Management and Minimization programs Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans Experience with clinical development including risk/benefit analysis and safety assessment Strong clinical, analytical, problem solving and scientific writing and communication skills We would prefer you have: Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Mastery of Microsoft Word, PowerPoint and Excel The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 02-Dec-2025 Closing Date 16-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $175k-263k yearly Auto-Apply 13d ago
  • Computational Biologist - Obesity Research

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Diabetes, Obesity and Complications Therapeutic Area (DOCTA) of Eli Lilly and Company focuses on new therapeutic approaches for the treatment of diabetes, obesity and cardiometabolic diseases. Starting from an idea, we work with partners across Lilly to discover and develop novel biologic, small molecule and nucleic acid-based therapeutics. Our focus is the patient: by understanding the biology and pathophysiology underlying disease states, we aim to address the root cause of disease, and develop breakthrough therapies. We have one of the strongest pipelines in the industry and a track record of delivering impactful medicines that improve people's lives. Are you a computational scientist passionate about addressing some of the most pressing global health challenges of our time? Do you stay current with the latest advances in metabolic disease research and obesity pathophysiology? Are you eager to apply pioneering computational and statistical approaches to analyze multi-omics data and unravel the complex biology of obesity, adipose tissue function and metabolic dysregulation? The computational biology role within DOCTA is an exciting opportunity for a team-oriented scientist with deep expertise in obesity biology and computation methods to drive therapeutic discovery in metabolic diseases. In this hands-on role, you will work cross-functionally with researchers across DOCTA to design and implement multi-omic studies specifically focused on obesity pathophysiology, energy regulation, adipose tissue biology, metabolic pathway dysregulation and CNS pathways concerning obesity. You will collaborate closely with experimental project leads and scientific domain experts to drive scientific discovery through the comprehensive analysis of single-cell genomics data from preclinical models and human studies. In this role, you will not only apply established computational methods to understand obesity pathophysiology and identify novel therapeutic targets in metabolic pathways, but also pioneer the application of innovative AI/ML approaches to extract deeper biological insights from complex multi-modal datasets. The successful candidate will have the opportunity to directly impact the DOCTA pipeline, ultimately driving the scientific field forward and bringing innovative therapies to patients. Key Responsibilities: Design and complete studies using omics-related data sources, including RNA-seq, spatial transcriptomics, single-cell omics, proteomics, functional genomics, metabolomics, and more. Integrate standard analytical approaches as well as emerging AI/ML models to answer scientific questions of high-dimensional data Partner with discovery statistics team to create novel analytical frameworks for high-throughput studies and develop specialized methodologies to enhance insights from small-sample datasets. Stay up-to-date on current technical and scientific advances through deep understanding of the literature and attendance of relevant technical and disease-related conferences Clearly communicate complex results to cross-functional partners in a prompt and transparent manner Perform ad-hoc bioinformatics analyses and data visualizations as needed Work collaboratively with other Data Sciences and Computational Biology (DSCB) scientists to develop innovative, best in class computational workflows and data repositories for advanced analyses Engage in code and documentation review within the team and across other teams within the DSCB team Adhere to industry-standard protocols for scientific project documentation Basic Requirements: PhD or equivalent in Computational Biology, Bioinformatics, Biomedical Informatics, or related field with 2+ years of experience post-PhD in relevant disease area. Additional Skills/Preferences: Strong track record of execution of computational biology and/or bioinformatics-based projects, potentially including RNA-seq, metabolomics, multi-omics, human genetics, proteomics, AI/ML, and other related research modalities required Prior experience and deep expertise in obesity and related areas, preferably with data from preclinical models, patient cohorts or cell lines preferred Expertise in programming languages including R and Python and experience with workflow management systems such as Nextflow required Experience developing production-grade bioinformatics pipelines, including working with standardized workflow tools preferred Experience with implementation and maintenance of industry-standard documentation practices including Git, Confluence, JIRA, or equivalent preferred Ability to prioritize and manage multiple competing priorities within a fast-paced environment required The ability to communicate complex scientific and computational concepts to non-computational and non-scientist audiences required Ability to represent the DOCTA DSCB team internally and externally required Strongly team-oriented thinking mentality required Prior industry experience preferred Experience with scalable cloud computing platforms (e.g. Databricks, AWS) and big data analytics frameworks preferred Experience with containerized technologies (e.g. Docker) for computational reproducibility preferred Knowledge of human genetics preferred Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $138,000 - $224,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $138k-224.4k yearly Auto-Apply 6d ago
  • Director - Neuroscience

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. We are seeking a highly motivated scientific laboratory leader with a solid background in Neuroscience to join our growing Psychiatry, Pain and Neuronal Health Team within Neuroscience Discovery Group at Lilly's Indianapolis Lilly Research Laboratories site. The ideal candidate will be a critical thinker with a deep understanding of Neuroscience and neuronal plasticity, with an emphasis on psychiatric and neurodevelopmental disorders. Successful candidates will have demonstrated abilities to lead a laboratory in industry and/or biotech that provides critical and robust decisional data. Demonstrated ability to develop preclinical in vivo biomarker assays, such as EEG, for translational early clinical phase development is desirable. The candidate will be an integral part of multiple cross-functional teams focused on developing novel medicines across broad neurological and psychiatric disorders. There is an expectation of effective communication skills and the ability to work collaboratively across the multiple geographies of Lilly's research sites, and strong leadership of cross-functional teams. Overall Responsibilities: * Supervise a group of dedicated laboratory neuroscientists. * Lead cross-functional teams in preclinical drug development phase. * Present data and conclusions to leadership and decision makers in a clear, balanced, and compelling manner. * Identify, develop, and implement innovative approaches to add functional capabilities and gain new insights into psychiatric and neurological disease biology, target engagement and pharmacodynamics. Basic Qualifications: * PhD in Biology, Biochemistry Neuroscience, Neurophysiology, or related scientific discipline with 10+ years industry or academic experience beyond any postdoctoral positions. * Alternatively, a Masters degree in Neuroscience, Neurophysiology, or related scientific discipline with 20+ years industry or academic work experience leading a laboratory and leading discovery projects through preclinical development Additional Skills/Preferences: * Clear understanding of pharmacology principles and measures of target engagement ex vivo or in vivo to drive human dose projections. * Demonstrated ability to lead a cross-functional team and translate preclinical biomarkers to clinical development. * Experience preparing document for regulatory filings. * Excellent communication and presentation of scientific skills. * Ability to work both independently and in cross-functional teams, as well as influencing beyond direct reports. * Demonstrated expertise in Neuroscience research as evidenced by peer reviewed publication record. Additional Information: * 20-30% travel * On Site position at Lilly Coporate Center in Indianapolis, Indiana and/or Lilly Seaport Innovation Center in Boston, Massachusetts Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $144k-250.8k yearly Auto-Apply 60d+ ago
  • Digital Consumer Experience Design

    Sanofi 4.3company rating

    Sanofi job in Cambridge, MA

    Job Title: Digital Consumer Experience Design About the Job Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve. About Sanofi EDGE: Sanofi EDGE - Building a Healthier Future, Together At EDGE, we're revolutionizing how individuals manage their health and well-being. We believe that lasting health behavior change is best achieved through a supportive ecosystem that includes not only clinical guidance but also the encouragement and practical assistance of a user's care circle. Our platform empowers individuals to set meaningful health goals, track their progress, and connect with their support network, all grounded in evidence-based principles and a deep understanding of human motivation. We're a passionate team dedicated to creating a user-centered experience that drives meaningful health outcomes and fosters long-term engagement. The Opportunity: We are seeking a talented and passionate UX/UI Designer to join our growing product and experience team. As a key member of the team, you will play a crucial role in shaping the user experience of our health management platform. You will be responsible for translating user needs, business requirements, and strategic goals into intuitive, engaging, and effective design solutions. You will collaborate closely with product managers, engineers, and researchers to create a seamless and empowering experience for our users and their care circles. Ideally, you will bring experience designing for consumer health applications, understanding the unique challenges and opportunities within this space. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: * Lead and contribute to the end-to-end design process, including detailed UI specifications and visual design. * Develop a deep understanding of our users, their motivations (in formed by self-determination theory), and their care circle dynamics through user research, usability testing, and data analysis in collaboration with product and user research team members. * Create user flows, wireframes, prototypes, and high-fidelity mockups that effectively communicate design ideas and solutions. * Design intuitive and accessible user interfaces that are consistent with our brand guidelines and design system. * Collaborate closely with product managers to define product features and translate them into user-centered design solutions. * Work effectively with engineering teams to ensure the successful implementation of designs. * Participate in design reviews and provide constructive feedback to other team members. * Stay up-to-date with the latest UX/UI trends, best practices, and technologies, particularly within the digital health landscape. * Contribute to the evolution and maintenance of our design system. * Advocate for the user throughout the product development lifecycle. About You Qualifications: * Bachelor's degree in Design, Human-Computer Interaction (HCI), or a related field, or equivalent professional experience. * Proven experience (ideally 3+ years) as a UX/UI Designer, preferably with experience in consumer-facing digital products. * Strongly preferred: Experience designing for consumer health applications, with an understanding of health data privacy (e.g., HIPAA), accessibility standards (e.g.,WCAG), and user behavior in health management. * A strong portfolio showcasing user-centered design solutions and demonstrating a clear understanding of UX principles and UI best practices. * Proficiency in industry-standard design and prototyping tools (e.g., Figma, Miro, Adobe XD). * Excellent communication, collaboration, and presentation skills. * Ability to work independently and as part of a cross-functional team in a fast-paced environment. * A strong understanding of user-centered design methodologies and the ability to translate research insights into actionable design decisions. * A passion for improving people's lives through thoughtful and effective design. * Familiarity with agile development processes. Bonus Points: * Experience designing for behavior change or social support platforms. * Knowledge of self-determination theory and its application in digital product design. * Experience working with design systems. * Understanding of front-end development principles (HTML, CSS, JavaScript). * Experience using AI to create workflow efficiency To Apply: Please submit your resume and a link to your online portfolio showcasing your relevant work. In your portfolio, please highlight projects that demonstrate your user-centered design process and your ability to solve complex design challenges. If you have experience in consumer health, please specifically call out those projects. Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $208,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $125.3k-208.8k yearly Auto-Apply 4d ago
  • 2026 Summer Internship Program: Environmental, Health, and Safety (EHS) Intern

    Takeda 4.7company rating

    Lexington, MA job

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Environment, Health and Safety (EHS) is responsible for ensuring MA Bio Ops maintains compliance with applicable EHS regulations, corporate EHS standards, and maintains the site's EHS management system. The team also focuses on reducing EHS risks at the site through the application of controls, as well as provide support to the site functions by partnering with them to assess risk, identify non-compliance, and to provide recommendations to mitigate both. The primary role of the EHS Intern is to support select EHS compliance activities across the Massachusetts Bio Operations Site. This could include supporting EHS functions within manufacturing, warehouses, laboratories and offices. Performing required inspections and investigations, gathering and analyzing data for reports and EHS software management, providing and developing training, assembling metrics and supporting sustainability initiatives will be core responsibilities. A strong focus will be placed on EHS project. How You Will Contribute: As a EHS Intern, you will have the opportunity to… Support EHS programs to ensure compliance with the latest regulations, best practices or corporate standards. Work with other Takeda departments and continuously improve data integrity, and compile metrics for internal or corporate reporting Support EHS related incidents investigations to determine causes. Help establish and implement corrective actions and make recommendations for areas needing improvement. May develop and deliver EHS training to all personnel as required by regulations and by Takeda standards and procedures. Gather and manage data related to the EHS programs working with other Takeda departments, consultants, and contractors. Internship Development Opportunities: Learn to work as part of a professional technical support team Learn how to assess risk and propose effective controls to reduce risk Job Requirements: Must be pursuing a Bachelors Degree in an EHS discipline such as environmental sciences or similar Creates an environment that inspires an inclusive and diverse culture Ability to prioritize projects and achieve exceptional outcomes Comfortable working through ambiguity Ability to promote change and encourage new ways of working Proactively takes steps to learn and grow Confidence working with data and emerging technology Internship Eligibility Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship Must be currently enrolled in a degree program graduating December 2026 or later The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st) The intern must be able to commit to one of these time frames Able to work full time 40 hours a week during internship dates Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program Program Highlights: Hands-on experience with real projects and responsibilities Dedicated mentorship program pairing interns with experienced professionals Networking opportunities with industry professionals and fellow interns Internship events focused on professional and skills development Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 7th - January 2nd Takeda Compensation and Benefits Summary We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MA - Lexington - BIO OPS U.S. Hourly Wage Range: $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: Paid sick time Civic Duty paid time off Participation at company volunteer events Participation at company sponsored special events Access to on-site fitness center (where available) Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MA - Lexington - BIO OPSWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time Job Exempt NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
    $28k-39k yearly est. Auto-Apply 20d ago
  • Corporate Counsel, Specialty Care

    Sanofi Us 4.3company rating

    Sanofi Us job in Cambridge, MA

    Job Title: Corporate Counsel, Specialty Care About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. Attorney with 3+ years of relevant pharmaceutical industry experience to join the Sanofi Legal Department as Corporate Counsel, responsible for Sanofi products (both investigational and marketed) managed by Sanofi's US and Global Specialty Care Business Unit. This role will also support day to day initiatives and long-term strategies. This is a broad business lawyering role that includes strategic and transactional counseling. The Corporate Counsel will need to be confident and comfortable with senior decision makers and be able to work independently across Sanofi at multiple levels. The Corporate Counsel will provide input on complex and sensitive legal and business issues and will advise his/her internal stakeholders in a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The Corporate Counsel will be expected to provide prompt, strategic, useful and thorough input to internal clients and management regarding complex and wide-ranging legal matters, particularly in the area of advertising and promotion, fraud and abuse and other applicable healthcare laws. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Serve as the primary legal contact for assigned products and/or business units in rare disease, oncology, immunology, rare blood disorders or neurology, acting as legal reviewer for advertising and promotional materials, as well as collaborating with other practice areas and functions relating to the assigned products and/or business units. Act as a partner to the business in considering, developing and executing initiatives relating to such products or business units. Manage the review and negotiation of certain contracts and amendments relating to the relevant product and/or business unit. The candidate must be flexible enough to manage multiple subject matter issues across diverse areas of the company, taking the initiative to identify appropriate subject matter experts and coordinating overall review. Work with cross functional stakeholders to assist them with adherence to Sanofi's policies, understand legislative developments that may impact our business, and work through direct and indirect management of both internal and external resources. This requires a high degree of organizational skill and focus on detail. The Corporate Counsel operates with limited supervision, and therefore requires a high level of balanced judgment and an ability to independently discern and establish priorities. Agility and willingness to learn about various subject matters (both from a legal and business perspective) are highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues and fraud and abuse) as well as proposed solutions to mitigate risk is required. The Corporate Counsel must demonstrate the following behaviors in partnering with cross-functional stakeholders: strategic business ownership, external awareness, impact-based counseling, proactivity, innovation, and focus on value creation. He/She must also know when to escalate issues internally and with outside counsel. Position to be based in Cambridge, Massachusetts. About You Basic Qualifications: BA/BS, Juris Doctorate degree from an accredited law school and a valid license to practice law (Massachusetts or New Jersey preferred) Minimum of 3 years of legal experience. Proficiency with Word, PowerPoint and other corporate standard software - required. Preferred Qualifications: Experience counseling pharma/biotech companies on FDA or other relevant governmental agencies on healthcare matters Experience with US and/or global legal support of scientific exchange and advertising and promotion of pharmaceutical products Professional Skills/Attributes: Excellent written and oral communication skills Team player with a commitment to developing strong collaborative relationships with legal colleagues, business stakeholders and cross-functional teams Demonstrated ability to understand legal principles and compliance, as well as business requirements Project management Commitment to proactively identifying opportunities for improvement and engaging with appropriate stakeholders to propose solutions Solutions-oriented; business-oriented Self-motivated, able to work independently, reliable, responsive, and accountable to deliver results High level of professionalism; strong interpersonal skills Proven ability/interest in working across a broad range of subject matter areas Strong organizational skills and ability to handle multiple responsibilities and priorities simultaneously and still meet high quality and timeliness standards under pressure Willingness to flex job responsibilities and learn new areas Strong interpersonal skills and proven ability to work collaboratively in cross-functional/multi-disciplinary teams Sound judgment and commitment to ethical conduct Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $208,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $125.3k-208.8k yearly Auto-Apply 60d+ ago
  • Associate Director - Clinical Operations

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs - VERVE-101, VERVE-102, and VERVE-201 - target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts. Responsibilities: Drive and oversee all aspects of clinical studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk-based approach. Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high-quality execution. Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals. Partner with cross-functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs. Partner with cross-functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on-time study enrollment. Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts. Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient-facing materials, and vendor plans). Assist in maintaining a quality-focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs. Engage in the planning of quality assurance activities and coordinate remediation of audit findings. Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed. Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost-effective execution, and punctual review of invoices. Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File (TMF) by performing periodic QC reviews to ensure the TMF is always "inspection ready”. Lead, mentor, and develop a high-performing team by fostering collaboration, resolving challenges, and ensuring peak performance. Provide training and guidance to junior staff to support their growth and expertise in clinical operations. Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities. Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values. Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies. Make data-driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation. Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment. Partner with internal teams and external partners to ensure seamless execution of clinical studies. Foster strong relationships across departments to align objectives, streamline workflows, and drive strategic decision-making. Basic Qualifications/Requirements: Bachelor's degree in a life science, allied health field, or other relevant field (e.g. nursing, medical or laboratory technology). At least 9 years of relevant experience. Additional Skills/Preferences: Proven ability to lead teams, manage projects, and solve complex problems. Strong communication skills, with the ability to persuade and influence partners in sensitive, high-impact situations. High emotional intelligence, with the ability to manage both your own emotions and those of others, fostering a collaborative and positive work environment. Skilled in conflict resolution and maintaining relationships in challenging scenarios. Experience managing contracts, budgets, resources, and schedules to meet performance and project requirements. Strategic thinker with the ability to clarify and structure ambiguous problems. Experience in policy development and implementation with potential company-wide effects. Ability to build and maintain strong team dynamics, proactively preventing and resolving challenges. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $127,500 - $187,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $127.5k-187k yearly Auto-Apply 46d ago
  • Discovery Lead - Women's Health & Musculoskeletal Biology

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, we are committed to advancing innovation in areas of high unmet medical need. With a proven track record in obesity research and a growing focus on women's health, we seek an experienced discovery leader to help build a portfolio of transformative therapies to improve outcomes for women everywhere and arrest age-related functional decline across genders. This role offers the opportunity to shape strategy, drive impactful drug discovery and development programs, and contribute to Lilly's mission of scientific excellence and patient-centered care. Position Summary: The Discovery Lead, Women's Health & Musculoskeletal Biology, serves as a pivotal leader responsible for establishing and advancing Lilly's portfolio in Women's Health and Age-related Functional Decline. Indications of interest include PCOS, endometriosis, preeclampsia, menopause-related disorders, osteoporosis and age-related decline in muscle function. We are looking for a dynamic and strategic leader with deep understanding of drug discovery, a passion for developing innovative medicines for areas of high unmet medical need, and a background in metabolic diseases, women's health and/or musculoskeletal biology. This leader will have a track record of identifying novel therapeutic approaches, progressing molecules to the clinic, and leading projects in drug discovery and development. Leading a team of 5-15 preclinical biologists, this role will direct research from target identification through preclinical development and collaborate across disciplines to progress projects through the preclinical and clinical portfolio. An important part of this role is the evaluation and progression of external opportunities: the Discovery Leader will work closely with Lilly's Catalyze 360 and business development organizations to enable the early-stage biotech ecosystem and bring external opportunities into Lilly. Portfolio Strategy and Discovery Leadership Shape Lilly's strategy in Women's Health and Age-related Functional Decline by combining a deep understanding of biology, current therapeutic landscape and competitive environment with evaluation of internal and external opportunities to build an industry-leading portfolio. Collaborate with clinical colleagues, new product planning and senior leadership to set overall program strategy and develop and maintain draft launch labels and value propositions that address key customer needs Lead evaluation of external partnership opportunities, make strategic recommendations to leadership, and ensure scientific leadership through execution and management Scientific and Portfolio Leadership Build, maintain and advance a portfolio of projects that have the potential to transform Women's Health and address key unmet needs in age-related functional decline. Partner closely with bioinformatics to bring computational approaches to bear on target selection and drug discovery Ensure state-of-the art biology capabilities in prioritized areas of Women's Health and Musculoskeletal Biology using internal and external resources. Ensure delivery of quality lead and candidate molecules. Establish and lead partnerships with academic institutions and biotechs to complement internal research efforts. Effectively represent Lilly in interactions with outside partners, key opinion leaders and collaborators. Engage in and lead advisory boards, target and portfolio reviews. Maintain a high scientific profile through publications and presentations Team Leadership & Management Supervise and mentor PhD and non-PhD scientists engaged in target identification, validation and preclinical drug discovery Supervise laboratories. Ensure adherence to all safety, quality and documentation requirements Lead cross-functional teams responsible for novel small and large molecule target discovery and validation Coach team members to think deeply and work creatively while delivering excellent scientific results Basic Qualifications: PhD or MD/PhD with a minimum of 10 years of experience in drug discovery in the pharmaceutical industry. Thorough understanding of drug discovery and development, including regulatory and IP considerations. Proven track record in moving projects forward with contributions to INDs and/or NDAs Significant scientific accomplishments as evidenced by high impact publications, patents or regulatory filings. Track record of successfully managing a diverse set of team-members in an industry setting. Able to deliver effective coaching and feedback. Qualified candidates must be legally authorized to be employed in the United States. Additional Skills/Preferences: Demonstrated ability to drive for results in a fast-paced environment Team-player who excels at working collaboratively while shaping project direction. Strong business sense and strategic planning and execution skills. Strong analytical and problem-solving abilities with excellent self-management and organizational skills. Passionate learner who embraces entrepreneurial thinking Excellent written and verbal communication skills Travel: Up to 25% US/Global travel Location: Boston or Indianapolis Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $345,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $113k-139k yearly est. Auto-Apply 20d ago
  • Postdoctoral Scientist - Antibody-RNA Conjugation, Genetic Medicine

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. We serve an extraordinary purpose. For more than 140 years, we have worked diligently to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. At the Lilly Innovation Center in Boston Seaport, Massachusetts, we explore how next generation therapeutics, new technologies, data analytics and new care models can improve patient health and the healthcare system. Our team in Boston shares a real passion for challenging conventional wisdom and creating an environment that embraces creative, break-through concepts. The Center offers a start-up environment with large company support. It is located in the heart of Massachusetts' exploding science and technology cluster and is within walking distance of some of the best academic and industry innovators in the world. We are seeking a highly motivated postdoctoral fellow to join our Genetic Medicine team at Eli Lilly in Boston MA. The successful candidate will possess a strong background in synthetic organic chemistry and experience in molecular design. They will be responsible for designing, synthesizing, and characterizing novel linkers for drug conjugates, with a focus on effective extrahepatic delivery. As part of a platform team, this individual will formulate linker chemistry strategies and investigate kinetics of payload-linker release to advance the RNA modality. Success in this role requires ability to solve complex problems, challenge the status-quo, and excel in communication and collaboration within a multidisciplinary team-oriented environment. Job Responsibilities: Develop novel linker strategies for antibody-RNA conjugates and bioconjugation methodologies. Design and synthesize novel linkers for controlled drug release. Collaborate closely with ADME teams to develop robust bioanalytical methods and to investigate PK/PD relationships for antibody-RNA conjugates. Contribute to optimization of internal antibody-RNA conjugate workflow. Work productively and safely in the laboratory; and maintain good practice in writing experimental reports in an electronic lab notebook. Communicate experimental results and project progress with supervisor and at team/department meetings. Publish/share original research externally (presentations, peer-reviewed articles, and conferences). Basic Qualifications: Ph.D. in synthetic chemistry, chemical biology, or related scientific field Additional Skills/Preferences: Extensive knowledge of cutting-edge modern organic chemistry, linker design and complex molecule synthesis. Understanding advanced analytical and purification techniques. Experience in antibody-drug conjugates and/or oligonucleotide chemistry will be preferred. Proficiency in independently executing research tasks. High learning agility in the field of new scientific concepts and drug modalities. Strong problem-solving skills with creative solutions in constructing complex molecular systems. A proven track record of significant contributions to research projects, substantiated by first or co-authorship on peer-reviewed scientific publications. A track record of productive collaborations in interdisciplinary team environment. Excellent communication and organizational skills Additional Information: This position is not permanent. It is for a fixed duration of two years with potential to extend to 3 years and for maximum of up to 4 years. You will have opportunities to apply for full time positions after your duration is complete Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $58,000 - $100,320 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $58k-100.3k yearly Auto-Apply 60d+ ago
  • 2026 U.S Summer Internship Program: Statistics and Quantitative Sciences Intern

    Takeda Pharmaceuticals 4.7company rating

    Boston, MA job

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences (DQS) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistics function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. **How You Will Contribute:** As an Intern, you will have the opportunity to + Conduct literature reviews and contribute to the prediction model development using various statistical methodologies. + Perform data analysis using SAS, R or python. + Support internal activities like team meetings in preparation of key program activities. + Use of AI enabled tools for efficiency in documents process. + Communicate findings and results effectively with cross-functional teams through written reports and oral presentations. **Internship Development Opportunities:** + Gain hands-on experience in applying statistical methodologies to drug development and clinical trial analyses + Develop an understanding of regulatory and compliance standards, including how regulatory guidelines influence statistical analyses in clinical trials. + Strengthen project and time management by contributing projects with defined timelines, deliverables and cross-functional collaborations. + Learn to apply machine-learning and predictive modeling techniques to support future study design and planning. + Enhance ability to communicate and justify statistical approaches when addressing questions from cross-functionals. **Job Requirements:** + This position will be Hybrid and require 2-3 days in the Cambridge office per week. + Must be pursuing a PhD in Biostatistics. + Strong understanding of machine learning concepts and their applications. + Experience in applying machine-learning methods to predict treatment outcome. based on baseline characteristics and selected post baseline biomarkers. + Familiarity with statistical techniques of model development and parameter tuning. + Proficiency in SAS and R programming languages for data manipulation and statistical analysis. Python experience is a plus. **Internship Eligibility** + Mustbe authorized towork in the U.S. on a permanent basis without requiring sponsorship + Must be currently enrolled in a degree program graduating December 2026or later + The internship program is 10-12 weeksdepending on the two start dates (May 26th-August 14thor June 15th- August 21st) + The intern must be able to commit to one of thesetime frames + Able to work full time40 hoursa week during internship dates + Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program **Program Highlights:** + Hands-on experience with real projects and responsibilities + Dedicated mentorship program pairing interns with experienced professionals + Networking opportunities with industry professionals and fellow interns + Internship events focused on professional and skills development + Exposure to multiple business areas or departments within a Pharmaceutical Organization Applications will be accepted between November 20th-January 2nd **Takeda Compensation and Benefits** **Summary** We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Boston, MA **U.S. Hourly Wage Range:** $21.00 - $46.00 The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. internship benefits vary by location and may include: + Paid sick time + Civic Duty paid time off + Participation at company volunteer events + Participation at company sponsored special events + Access to on-site fitness center (where available) + Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Boston, MA **Worker Type** Employee **Worker Sub-Type** Paid Intern (Fixed Term) (Trainee) **Time Type** Full time **Job Exempt** No It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
    $21-46 hourly 23d ago
  • Pharmaceutical Sales Specialist - Respiratory Specialty - Worcester, MA

    Astrazeneca 4.6company rating

    Worcester, MA job

    At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Specialty Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Accountabilities - Develop and demonstrate strong knowledge of clinical disease states and treatment guidelines. - Effectively communicate product information to healthcare professionals to influence prescribing behavior. - Execute call plans and Brand Strategy by translating data to actionable insights. - Build and maintain working relationships with healthcare professionals. - Drive portfolio demand performance through meaningful customer interactions leveraging multiple channels, such as digital platforms and face-to-face engagements to reach the customers. - Demonstrate openness to new ideas and seek innovative approaches to sales and customer engagement. Essential Skills/Experience - Bachelor's Degree - 2+ yrs of demonstrated Sales or Commercial experience or a combination of: pharmaceutical, healthcare, scientific, clinical, institutional or related industry experience - A valid driver's license and safe driving record Essential Skills and Capabilities - Customer Engagement: Demonstrated commitment to improving patient outcomes through effective engagement with healthcare professionals. - Advanced Sales Techniques: Experience with advanced sales techniques and strategies tailored to specialty care markets. - Clinical Acumen: Strong understanding of clinical trial data and the ability to communicate complex scientific information clearly. - Business Acumen: Ability to conduct detailed market analysis and leverage insights for strategic planning. Desirable Skills/Experience - Therapeutic area experience, specialization in clinical setting, and sales experience At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our inclusive team draws on diverse backgrounds, skills, and experiences to create innovative solutions that make a difference. Join us in making a meaningful impact on patients' lives by applying today! The annual base salary (or hourly rate of compensation) for this position ranges from $107,172 -$160,758. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 12-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $107.2k-160.8k yearly Auto-Apply 3d ago
  • Biostatistics Evidence Generation & Decision Sciences (EGDS)- Summer 2026 Intern

    Sanofi 4.3company rating

    Sanofi job in Cambridge, MA

    About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our B&P Neurology team as a Data Analyst and you'll lead one or several late phase studies, or lead an indication for a complex compound, under supervision of statistical project leader and/or team leader. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: * Contribute to the design and analysis of both early- and late-phase clinical trials by applying advanced statistical methods and data analysis techniques. * Support the development, evaluation, and implementation of innovative statistical methodologies to address complex problems in clinical research. * Work collaboratively under the guidance and mentorship of senior-level statisticians, gaining hands-on experience in study planning, data interpretation, and the preparation of statistical reports and publications. About You Basic Qualifications: * Currently enrolled and pursuing PhD in Statistics or Biostatistics at an accredited college or university * Candidates must have completed at least two years of graduate coursework and be working on a dissertation toward a PhD in Statistics or Biostatistics * Experience with SAS and R * Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship * Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship Preferred Qualifications: * Effective oral and written communication skills * Experience with python is a plus Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Exposure to cutting-edge technologies and research methodologies * Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
    $39k-46k yearly est. Auto-Apply 12d ago
  • Head of Material Planning

    Sanofi 4.3company rating

    Sanofi job in Framingham, MA

    Job Title: Head of Material Planning About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Supply Chain organization is responsible for all supply chain activities across the Massachusetts BioCampus. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: PCU Material Planner Team Member responsibilities are: * Makes sure the 3rd party materials are planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations • Reporting of deviations to coverage targets to Critical Material Manager (GSP) * Reviews SAP requisitions or Site Scheduler requests for Purchase Requisitions * Converts Purchase Requisitions sent by Site Scheduler into Purchase Orders, considering factors such as current inventory levels, safety stock policies, material coverage, , and supplier agreements. * Sends Purchase Orders/Schedule lines to suppliers, respecting suppliers' Lead Time, and updates supplier confirmation for each Purchase Order (order acknowledge) in the system so reception dates are available for the site logistic operations in the system if EDI is not established. In case EDI is in place the Material Planner checks the confirmed date and gets in contact with the scheduler or planner if the confirmed delivery date shows a discrepancy of more than +/-10 days * Assesses the availability of materials. * Collaborate with the quality team to secure the release on-time for third party purchasing materials and the reflection of this time in the ERP system to ensure master data correctness * Manages material issues with Site Planner or Scheduler, depending on the horizon of the issue. * Connects with suppliers to monitor the status of the supply plan and to detect exceptions to it as soon as possible to be able to address them. * Coordinates with Critical 3rd Party Material Planner (GSP) if any risk of material shortage cannot be addressed at the site level. * Support warehouse and/or quality teams in complaint management and related deviations * Communicates monthly rolling forecast to up to 36 months, confirming suppliers' capacity in collaboration with Site Scheduler and Supply Planner. * Provides Forecasts, OTIF data, etc. To Critical 3rd Party Material Planner (GSP) for Supplier S&OPs or Global Supply Review * Ensures system is updated (in terms of supplier feedback to requested supply) for Critical 3rd Party Material Planner (GSP) to be able to get the mid to long-term forecast from the system. * Ensures purchased materials are delivered in time for testing release and use. * Monitor issues regarding shipping and returns. * Track supplies' performance metrics. * Initiate conversation with suppliers and Critical 3rd Party Material Planner (GSP) in case of deviation from expected performance. * Communicate the need for qualifying new suppliers to procurement in case of materials shortages from existing suppliers. * Support the quality related topic for 3rd party materials, including creation and monitoring of change control request (CCR) related to supplier changes/ supplier notifications, new products, etc. • Analyzes and proposes updates to Master Data to enhance industrial performance. * Ensures critical (leadtime > frozen horizon) or high value (ABC > 80% of value) material is flagged as KX relevant and MRP is done in KX unless exception conditions met (VMI in SAP, Quota management in SAP, etc.) and creates BuyBODs The PCU meeting roles of the PCU Material Planner Team Member are: * Leads the MRP Meeting * Contributes to the Level 1 Supply Chain +QDCI meeting * Contributes to the Handover to Scheduler meeting * Contributes to the Transparency meeting * Contributes to Capability Review in case of capacity limiting Material Constraint CI loop contribution of PCU Material Planner Team Member includes: * Collaborating with data steward and suppliers to maintain MRP Data in systems (MOQ, Lead Times, Safety Stocks, etc.). * As DCO, analyzing and preparing proposal of Master Data Evolution to support the industrial performance. Takes responsibility for the availability of components to enable production orders. * Tracks suppliers OTIF and performs root cause analysis for planning changes and action plan follow-up. * Manages performance of Suppliers (OTIF) linked with KSOL. Manages Critical Material (materials at risk and critical suppliers) Key Involvement in Decision-Making Process Key Roles (D,A,I) * A/I: Prepares key insights for Supplier S&OPs, key advisor to identify critical * materials in alignment with Critical Material Manager GSP * A/I: Key advisor in CI initiatives related to material planning, * D: Takes care of implementation of CI initiatives * A/I: Strongly involved in setting thresholds for 3rd party Material in system (e.g., high stock values, long lead times, VMI) About You Basic Qualifications * Bachelor's Degree * 10+ years of materials, purchasing or supply chain experience * 5+ years of supervisory experience * 5+ years of experience working with SAP and inventory management systems * Excellent communication skills * Proficient with MS office applications Preferred Qualifications * Bachelor's Degree in a science or technical field * Experience in pharmaceuticals or a related industry * APICS Certification and 10+ years' experience using SAP, and Oracle strongly desired * Strong understanding of planning and purchasing systems in a CGMP manufacturing environment * Project management skills * Expertise in document management systems * Knowledge and understanding of biopharmaceutical CGMP manufacturing preferably in large scale commercial biologics manufacturing required. * Solid understanding of quality, supply chain, finance and planning * Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions * Knowledge and experience with discrepancy investigation and lot disposition. Disclaimer The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship. Why Choose Us * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $114,750.00 - $165,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $114.8k-165.8k yearly Auto-Apply 48d ago
  • Planning and Scheduling Specialist

    Sanofi 4.3company rating

    Sanofi job in Framingham, MA

    Job Title: Planning and Scheduling Specialist About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. This organization is responsible for providing Facilities, Engineering and Maintenance support for all cGMP process and utility systems at Framingham MA Campus, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is also responsible for shared GMP and non GMP systems on the Framingham campus as defined by Service Level Agreements and this role will support key campus stakeholders including but not limited to Research & Development, Science, Global Manufacturing Sciences and Technology. This organization is also responsible for non GMP maintenance of buildings on the Framingham campus in conjunction with North America Sanofi Business services (SBS) and is the main group interfacing with SBS. Takes a lead role in matters related to asset management, PM program and planning and scheduling of preventive and unscheduled maintenance activities. Contributes to continuous improvement projects and initiatives. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Maintains the Computerized Maintenance Management System (CMMS) to plan and schedule work orders, preventive maintenance activities, material lists and asset management. Receives all work orders from requesting departments and end-users. Assess work request and makes decisions regarding response time and level of planning activities based on priority of requested work. Adapts to changing production needs and prioritizes work among conflicting schedules and expectations. Develops maintenance work packages by evaluating work orders for required permits, action notices, job steps, spare parts, tools, labor and opportunities for efficiencies. Ensures estimate for time required to perform work activities are accurate for the purpose of establishing a schedule. Utilizes reports to optimize schedule and level loading of resources. Works in a collaborative team environment and interacts with other departments such as Engineering, Facilities, Validation, Quality, Manufacturing, and Metrology. Team member or lead for special projects as assigned. Acts as subject matter expert for work order management, asset management and PM program. Supports audit requests and CMMS training. Meets with production and area owners to finalize equipment availability and schedule upcoming maintenance activities. Utilizes maintenance reports/metrics to manage incoming and future work activities. Acts as Shutdown Coordinator or participates in the coordination and scheduling of building and utility shutdowns. About You Basic Qualifications High School Diploma with 3+ years planning or scheduling or related work experience. Strong organizational, administrative, and analytical skills. Working knowledge of Computerized Maintenance Management System (CMMS), Computerized Calibration Management System (CCMS) Experience working within cross-functional teams. Working knowledge of quality management systems. Customer service oriented, works well with internal and external customers. Preferred Qualifications Experience working for a maintenance organization in a cGMP Biotech/Pharmaceutical manufacturing environment. Knowledge of methods, materials, tools and equipment used in the maintenance of a modern pharmaceutical facility. Knowledge of industrial and manufacturing equipment with the ability to help coordinate building shutdowns. Ability to identify potential safety hazards, LOTO requirements, and appropriate precautions applicable to work assignments. Experience in a Enterprise Asset Management System. Special Working Conditions Ability to gown and enter clean rooms. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $35.56 - $47.41 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $35.6-47.4 hourly Auto-Apply 29d ago
  • PCP/Endo Business Specialist-Boston North

    Boehringer Ingelheim 4.6company rating

    Boston, MA job

    The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Compensation Data** This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Duties & Responsibilities** + Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. + Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. + Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. + Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. + Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. + Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. + Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. **PCP/Endo Business Specialist Requirements** Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. **Executive PCP/Endo Business Specialist** Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $95k yearly 37d ago

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