Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote Opportunity - Open to candidates within the United States, preferably on the East Coast Summary Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations. Essential Functions - Serves as regulatory CMC representative on development and marketed product teams. - Responsible for advising teams on regulatory authority expectations and guidelines and ensure the CMC regulatory strategy is in alignment with the global strategy and with the Target Product Profile. - Manage interactions with Health Authorities for assigned project(s) to ensure acceptance, rapid review and approval of initial marketing applications, supplements/variations, and other submissions which present CMC information. - Maintains an in-depth level of understanding of the company's compounds, their characteristics, manufacturing aspects and specifications/analytical methods. - Responsible for the timely completion of well-organized, scientifically sound regulatory CMC submissions, to include DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc. and required amendments. Hands-on participation in submission preparation is expected. - Coordinate preparation and review technical reports and CMC sections of global submissions to support clinical investigation and marketing applications. - Ensure compliance with regulatory requirements, strategies, and commitments, which may require partnerships with CRO's or others who work on the company's behalf. - Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes. - Support CMC QA functions, e.g deviations, general GMP/regulatory mixed topics. - Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate. - Maintains an advanced level of understanding and awareness of existing and forthcoming legislation to advise project teams accordingly. Required Education, Experience, and Skills - Accredited bachelor's degree - Minimum of eight (8) years of experience in the Pharmaceutical, Biotech or Medical Device Industry with direct experience with small molecule/biologic technical functions. - Minimum of five (5) years of experience in Regulatory CMC with progressive experience in supporting global programs from pre-approval or post-marketing. - Capability to interact with CMC technical experts regarding process development and analytical issues. - Demonstrated success in global submission filing, approval, and lifecycle management. - Demonstrated ability to proactively and effectively influence peers, external colleagues, and across all levels of management. Preferred Education, Experience, and Skills - Bachelor of Science or Arts Degree; life science related degree - Master or PhD of Science - Combination product (drug/device) experience Travel Requirements - Willingness/Ability to travel up to 10 % international travel will be required. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $225,000 - $255,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: R&D Digital Job Category: People Leader All Job Posting Locations: Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America Job Description: Johnson & Johnson MedTech is seeking an Associate Director, Research & Development Data Governance. Who are we? At Johnson & Johnson MedTech, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com The MedTech Regulatory Affairs and R&D Data Office (RADO), is responsible for establishing the data governance process and applying consistent data governance standards across Regulatory Affairs and R&D, as part of a unified MedTech data strategy under the MedTech Data Office (MTDO). The aim is to ensure consistent data governance and standards across functions and enable trusted, well governed data to sustain our competitive edge. Purpose of the role - As Associate Director, Research & Development Data Governance, you will be responsible for leading the strategy, development, and execution of R&D data governance initiatives across MedTech. This role ensures the integrity, consistency, and usability of data within R&D systems. The position collaborates with cross functional stakeholders, including Business Unit and Regional R&D teams, PLM teams, Data Analytics, and Quality teams, to establish standardized data definitions, processes, and controls that support regulatory compliance, operational efficiency, and data driven decision making across the enterprise What to expect: R&D Data Governance Strategy & Leadership - Lead the end-to-end development, implementation, and maintenance of the R&D Data Dictionary, including data elements ownership, critical data attributes definition, and alignment across global stakeholders. - Drive alignment among Data Stewards and functional partners to standardize R&D data constructs and reduce interpretational variability. - Chair and manage Data Governance forums, workshops, and cross functional working sessions to support decision‑functional working sessions to support decision making‑making and process alignment. Data Quality Management - Oversee the remediation, alignment, and rationalization of R&D Data, including mandatory and optional data elements. - Lead data cleansing initiatives. - Develop and deploy dashboards (e.g., Power BI) to monitor remediation volume, data accuracy, and quality improvements. Data Contracts & Cross Functional‑Functional Data Usage Governance - Provide expert guidance on the creation, review, and standardization of data contracts for MedTech teams. - Support triage and evaluation of data usage requests to ensure appropriate R&D data governance and compliance. - Develop standard templates and frameworks to enable consistent cross functional‑functional usage of MT R&D data. Continuous Improvement, Training & Change Management - Deliver training programs on R&D data foundations (data quality, data governance, data management, etc.) for internal stakeholders and career development cohorts. - Facilitate feedback sessions with Data Stewards to strengthen collaboration, refine processes, and improve data governance practices. - Promote a culture of high data quality, transparency, and operational excellence within the regulatory environment. Leadership & Talent Development - Mentor regulatory professionals through formal programs such as J&J Learn. - Demonstrate and model J&J Leadership Imperatives (Live Our Credo, Connect, Shape, Grow) through daily actions, cross functional‑functional influence, and capability building. - Lead by example to foster a collaborative, inclusive, and learning oriented‑oriented R&D community. Who are we looking for? - Degree or Master’s preferred within either Engineering, Life Sciences, Research & Development, Information Management, or related fields - Preferred Related Industry Experience, Research & Development, Supply Chain, Quality - Minimum of 10 years of experience in Research & Development, quality, regulatory, or related fields, with at least 5 years of experience in regulated industry - Strong understanding of MedTech global markets (e.g., US, EU, China, Brazil). - Proven leadership in data governance, R&D systems, and master data management - Demonstrated strong leadership, organizational, and planning skills with the ability to work cross-functionally with global teams and a diverse work force and customer base. - Excellent communication skills, with the ability to clearly articulate technical concepts to non-technical stakeholders, to build and maintain relationships, and to quickly build credibility at all levels in the organization. - Highly skilled in establishing partnerships within function, successfully influence senior leaders and able to work collaboratively in a highly matrixed environment. - Strong problem-solving skills with the ability to identify and resolve complex data management and analytics issues. - Strategic thinking and ability to partner with internal stakeholders at all levels of the organization. - Ability to achieve results under demanding time constraints with expansive and changing priorities. - Experience with Research & Development digital systems - Ability to analyse complex datasets and develop actionable insights - Experience designing and delivering training programs What type of mark will YOU make? By joining Johnson & Johnson MedTech you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything. What’s in it for YOU? It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Johnson & Johnson: Changing health for humanity We’re building a world where complex diseases are prevented and cured, treatments are smarter and less invasive—and solutions are personal Required Skills: Preferred Skills: Consulting, Data Savvy, Data Structures, Developing Others, Digital Fluency, Digital Strategy, Emerging Technologies, Engineering, Global Market, Inclusive Leadership, Leadership, Negotiation, Operations Management, Product Development, Research and Development, Risk Assessments, SAP Product Lifecycle Management, Tactical Planning The anticipated base pay range for this position is : $137,000.00 - $235,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail. This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes. Where you come in: - You will be the accountable Quality leader for Dexcom's on market Product Sustaining Teams. This includes: - Acting as the leader on Dexcom Platform Core Teams representing the Quality function - Supporting strategy, resourcing, execution, and delivery of Dexcom Platform Core Team commitments associated with Design Changes, Supply Continuity, Global Expansions, and Issue Resolution in alignment with DfX, Design Controls, SDLC, Risk Management, CAPA, and HHE expectations. - Managing escalations, navigating to solutions, and acting as the Quality function decision maker for your respective platforms- including shifting resources between Platforms when appropriate and influencing your cross functional peers and leaders. - Post Market Risk Management leadership - You will act as the Quality lead for Product Remediation Planning and Activities driven through CAPA or Quality Improvement Plans at Dexcom. - You will be responsible for leading, developing, and growing an organization of Design Quality Engineers and Managers while ensuring required levels of quality engineering support are provided to Platform teams. - You will represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, design controls, risk management, and issue resolution through CAPA and HHE as applicable. - You will promote cross-functional understanding and adherence to quality standards, quality processes, and regulatory requirements. What makes you successful: - You have proven experience in Design Quality Engineering and Assurance within the medical device industry. - You must have a minimum of 10 years of experience in medical device development. - You bring at least 5 years in progressively responsible leadership roles. - You demonstrate an ability to adapt to shifting priorities and manage multiple initiatives. - You possess exceptional interpersonal, written, and verbal communication skills. - You are self-motivated with a collaborative, proactive, and accountable approach. What you’ll get: - A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. - A full and comprehensive benefits program. - Growth opportunities on a global scale. - Access to career development through in-house learning programs and/or qualified tuition reimbursement. - An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: - - 15-25% Experience and Education Requirements: - Typically requires a Bachelor’s degree with 13+ years of industry experience - Requires a degree in a technical discipline - 5-8 years of previous people management experience Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $164,200.00 - $273,600.00

Responsibilities - Build a strong long-term technology strategy that aligns with company strategic plan and influences the overall company direction, in close partnership with executive leadership - Recruit, hire and grow a team of software/test/devops engineers working across a number of software platforms (java, C#, javascript and iOS/Android). Align and inspire your team by effectively communicating and engaging the team in the strategy. - Operate as a player-coach (25:75) staying technically involved with a small, tightly aligned team (~12 people); Includes instill software development lifecycle best practices on code review, testing, automated CI/CD and issue/bug triage - Own the entire scope of software development for the Autoimmune business unit, including: - Responsibilities include overseeing the creation, development, and design for the following areas: - Business Logic - this function sits at the intersection of all operations inside the organization, including logistics, medical billing, payments, financial systems, customer service and CRM, ETL (business intelligence) and test ordering. - Digital Consumer Interfaces - create a modern experience in healthcare with the goal to deliver engaging experiences for our patients and providers to manage Rheumatoid Arthritis (RA) disease progression. Includes developing native mobile and web applications for engaging patients daily on their pain management. - LIMS, Genomics and Operations - Develop systems to support lab workflows and informatics to deliver high quality and fast genomic results, at scale (thousands of samples a month). Engineers challenges span sample workflows, archival, accessioning and data management, quality review and report generation. Qualifications - Excellent communication skills both written and verbal - Self starter and team builder - 7+ years experience leading technical teams - Demonstrated coding ability in one or some of the following areas along with : Java, C#, JavaScript (Angular), Python and SQL - BS, MS or PHD in Computer Science or equivalent experience; MS or PhD in Computational Biology or related field a bonus; - Demonstrated experience building software in a regulated environment such as healthcare, banking or government - Demonstrated experience leading multidisciplinary teams - Experience with commercial LIMS systems (e.g., LabVantage) and Salesforce CRM is a plus - Knowledge in agile methodologies and software development lifecycle Ready to transform the future of patient care through the power of genetics? For more than 30 years, Myriad Genetics has led the way in precision medicine by delivering important insights to help people make informed health decisions. As a leading molecular diagnostic testing and precision medicine company, we are dedicated to advancing health and well-being for all. Our innovative genetic tests are used across specialties including oncology, women’s health, and mental health, empowering clinicians to personalize treatment and help their patients take proactive steps toward better outcomes. What inspires us – and you – is simple: Every test, every insight, and every patient story emphasizes our commitment to improving lives through science, innovation, and care. you’re ready to help shape the future of medicine. Your work will have meaningful impact, and your dedication can change lives. Learn more at https://www.myriad.com and follow Myriad Genetics on LinkedIn. We are an equal opportunity employer and place high value on inclusion and belonging. We prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants’ and employees’ religious practices and beliefs, as well as any mental health or physical disability needs. If you need assistance submitting your application due to a disability, you can request an accommodation by contacting recruiting@myriad.com. Please answer all questions completely. Please do not provide any information not specifically requested on this Employment Application form. To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Myriad Genetics will never request payment, solicit personal financial information, or conduct interviews via informal channels (e.g., personal email, text messages). All opportunity-related communication with Myriad Genetics will come from our employees, whose e-mail addresses end with "@myriad.com."