Sr Associate Software Engineer - Regulatory Structured Submission
Emedgene, an Illumina Company
- Remote job
Career Category
Information Systems
Job Description
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Sr Associate Software Engineer – Regulatory Structured Submission
What you will do
We are seeking an experienced VBA Automation Developer to work on a GxP platform supporting the automation of regulatory content. A proficient VBA developer should have a solid understanding of VBA programming and MS Office macro working, including syntax, functions, and debugging techniques. The ability to automate repetitive tasks using VBA, including creating macros to streamline processes and improve efficiency, is essential. Experience in designing user-friendly interfaces within MS Office applications, including creating forms, buttons, and other interactive elements, is valuable. Proficiency in implementing robust error handling and debugging techniques to ensure code reliability and maintainability is crucial. The ability to document code and processes clearly, ensuring that others can understand and maintain the codebase, is necessary. Strong analytical and problem-solving skills to identify issues and develop effective solutions are also required.
- Familiarity with MS Word templates and Appian programming
- Ability to review and analyze existing VBA code to understand its structure and functionality.
- Skills in customizing and enhancing existing code to meet new requirements, including adding new features and modifying existing ones.
- Proficiency in testing and validating changes to ensure they meet the specified requirements and do not introduce new issues.
- Ability to work collaboratively with stakeholders, including regulatory experts, to gather requirements and ensure that changes align with regulatory standards.
- Solid understanding of Visual Basic language, including syntax, functions, and debugging techniques.
- Ability to automate repetitive tasks using VBA, including creating macros to streamline processes and improve efficiency.
- Proficiency in implementing robust error handling and debugging techniques to ensure code reliability and maintainability.
- Ability to document code and processes clearly, ensuring that others can understand and maintain the codebase.
- Strong analytical and problem-solving skills to identify issues and develop effective solutions.
- Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications.
Basic Qualifications:
- Master's degree / Bachelor's degree and 5 to 9 years of relevant experience
Must-Have Skills:
- Experienced in VBA Development, Appian programming, MS Office Macros and MS Office automation.
- Experience of engaging with Business stakeholders for gathering requirements, demonstrating the capabilities developed and taking feedback for continual improvement.
- Good to have 4-5 years of experience in the Pharmaceutical Industry
- Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
- Experience with Agile software development methodologies (Scrum)
- Good communication skills and the ability to work with senior leadership with confidence and clarity
- Experience in writing requirements for development of a modern web application
- Proficiency in automation tools, data systems, and validation software.
Good-to-Have Skills:
- Demonstrated expertise in a scientific domain area and related technology needs
- Understanding of scientific software systems strategy, governance, and infrastructure
- Familiarity with low-code, no-code test automation software
- Technical thought leadership
- Able to communicate technical or complex subject matters in business terms
- Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology
Professional Certifications:
- SAFe for Teams certification (preferred)
Soft Skills:
- Able to work under minimal supervision
- Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work
- Excellent analytical and gap/fit assessment skills
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
- ...vital role you will play a key role in a regulatory submission content automation initiative which... ...technologies, including Generative AI, Structured Content Management, and integrated... ...Description: We are seeking a highly skilled Software Engineer to join our team. You will...SeniorRegulatoryRemote jobFull timeLocal area
- ...lives of patients while transforming your career. Senior Associate Full Stack Software Engineer What you will do Let’s do this. Let’s change the... ...to minimize downtime. You will play a key role in a regulatory submission content automation initiative which will...SeniorRegulatoryRemote jobFull timeLocal area
- ...part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate IS Business Systems Analyst - Regulatory Structured Submissions What you will do In this role, you will participate and lead Scrum events and processes for...RegulatoryRemote jobFull timeLocal areaShift workNight shiftAfternoon shift
- ...designing, developing, and maintaining software applications and solutions that meet business... ...product managers, designers, and other engineers to create/maintain high-quality,... ...management to ensure process compliance with all regulatory and Amgen procedural requirements....SeniorRegulatoryRemote jobFull timeLocal area
- ...role you will facilitate Scrum events and processes for the Regulatory Structured Submissions Team. Your responsibilities include enhancing team... ...The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile framework practitioner...RegulatoryRemote jobLocal areaShift workNight shiftAfternoon shift
- ...with osteoporosis yet. We’ve built software to help us select clinical trial sites... ...and accelerate the authoring of regulatory documents so we can shorten the drug... ...Join us! We are seeking a Senior Associate Backend Software Engineer to join the Lab’s software engineering...SeniorRegulatoryRemote jobFull time
- ...background in the end-to-end software development lifecycle and a Scaled... ...in a matrixed organizational structure. Roles & Responsibilities:... ...product owners, validation engineers, scrum masters and business... ...strategy, compliance, and regulatory requirements for technology investments...RegulatoryRemote jobFull timeFlexible hours
- ...for designing, developing, and maintaining complex software applications with guidance from senior software engineers. This role involves working closely with product... ...Experience with design patterns, data structures, & test-driven development Experience with monitoring...SeniorRemote jobFull time
- ...transform the lives of patients while transforming your career. Sr Associate IS Analyst - docuBridge What you will do Sr Associate... ...a key role in implementation and lifecycle management of structured regulatory submission solutions, with a main focus on Lorenz DocuBridge...SeniorRegulatoryRemote jobFull timeLocal areaFlexible hoursShift workNight shiftAfternoon shift
- ...while transforming your career. Senior Manager - Regulatory Data Management What you will do The Global Submission and Information Management (GSIM) team brings... ...and systems. Strong Knowledge of handling structured and unstructured data Demonstrated excellence...SeniorRegulatoryRemote jobFull timeLocal area
- ...what’s possible. Title: Medical Director/Sr. Medical Director, Clinical Development... ...Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment... ..., investigator brochures, and regulatory submissions. ~Medical review, analysis, and...SeniorRegulatoryHybrid workRemote job
- ...you will act as the Quality Engineering representative on multi-functional... ...and standards. The Sr Quality Engineer will be an integral... ...and non-combination products associated with final product activities... ...to content and review of regulatory submissions and RTQs, and support...SeniorRegulatoryRemote jobLocal areaShift work
- ...studies in accordance with GCP and regulatory requirements. This individual... ...Remote eligible Reports To: Sr. Director, Clinical Research... ...forms, safety updates, and submission materials. ~Support clinical... ...experience with data visualization software (e.g., GraphPad Prism) ~...SeniorRegulatoryRemote job
- ...background in the end-to-end software development lifecycle and a Scaled... ...in a matrixed organizational structure. Roles & Responsibilities:... ...product owners, validation engineers, scrum masters and business... ...strategy, compliance, and regulatory requirements for technology investments...SeniorRegulatoryRemote jobLocal areaFlexible hours
- ...using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The Sr. Associate Software Engineer collaborates with Salesforce/Veeva CRM Admins, Data Engineers, and Architects to streamline the delivery of Veeva CRM/...SeniorRemote jobFull time
- ...lives of patients while transforming your career. Senior Associate Software Engineer What you will do Let’s do this. Let’s change the world.... ...Operations functions. . Role Description: As a Full Stack Sr Associate Software Engineer, you will contribute to the...SeniorRemote jobFull timeLocal area
- ...A Senior Associate must have an understanding of the organization’s basic consulting models and methodologies, as well as basic knowledge... ...meeting and follow-ups Reg Vault: creation of RO & SO and Submission content plan Drafting of Cover Letter, Application forms...SeniorRegulatoryRemote jobShift work
- ...Position Overview Kyverna is recruiting for a Sr. Director, Clinical Scientist with deep... ...with GCP, company policies, and regulatory requirements. This role will lead the scientific... ...safety updates, annual reports, BLA/CTA submission materials, and responses to Health...SeniorRegulatoryLocal areaRemote job
- ...transforming your career. Sr. Manager Infomation Systems... ...background in the end-to-end software development lifecycle and a Scaled... ...in a matrixed organizational structure Lead a team responsible for... ...Amgen, ensuring compliance with regulatory standards (e.g., FDA, GxP) throughout...SeniorRegulatoryRemote jobFull timeLocal area
- ...Job Summary: The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical... ...collaboration, proactive risk management, and strong regulatory expertise. Key Responsibilities: Lead end-to-end CTA...SeniorRegulatoryRemote job
- ...Senior Regulatory Affairs Associate will be responsible for managing and maintaining regulatory data, supporting EMA submissions, and ensuring compliance with European regulatory requirements. The role involves hands-on experience with xEVMPD, Veeva Vault RIM, and lifecycle...SeniorRegulatoryRemote job
- ...strong expertise in Oracle Argus Safety, Pharmacovigilance systems, regulatory compliance, and SQL/PL-SQL development. The successful... ...business configurations.- Support E2B R2/R3 regulatory reporting, submissions, and mapping activities.- Troubleshoot system issues and implement...SeniorRegulatoryFull time
- ...you can be proud of. UX/UI Engineer Live What you will do... ...researchers, clinicians, and regulatory professionals quickly find the... ...UI wireframes to facilitate software development ~ Familiarity with... ...~ Understanding of database structures. ~Experience in overseeing...SeniorRegulatoryRemote jobLocal areaWorldwide
- ...patients while transforming your career. Sr Associate Supplier Quality What you will do... ...in compliance with corporate and regulatory requirements, to ensure alignment with... ...qualifications: Bachelor’s degree in science or engineering and 2+ years of professional experience...SeniorRegulatoryRemote jobFull timeLocal area
- ...addressed with utmost precision. As the Sr Associate Data Scientist at Amgen, you will be responsible... ..., and statistical methods to uncover structure in large data sets. This role involves... ...customer service. Collaborate with regulatory and compliance teams to ensure adherence...SeniorRegulatoryRemote jobFull timeLocal area
- ...thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Associate Software Engineer The Sr Associate Software Engineer will assist in designing, developing, and maintaining software applications and solutions...SeniorRemote jobFull timeLocal area
- Role Overview : As a Senior GCP Data Engineer, you will be instrumental in designing, building... ...sensitive information and ensuring regulatory adherence for our clients.- Troubleshoot... ...providing a strong foundation in computational principles and data structures. (ref:hirist.tech)SeniorRegulatoryHybrid workRemote job
- Kyverna is a cell therapy company engineering and developing a new class of curative living... ...and assess, recommend, and implement the structure and capabilities needed to grow the function... ...with cGMP manufacturing as well as regulatory requirements for biopharmaceutical products...SeniorRegulatoryFull timeContract workTemporary workRemote job
- ...Goods Management, Hazardous Substance Management, Substance Volume Tracking, Global Label Management, WWI Template design, EHS Regulatory Content Update. # Secondary skill and fair knowledge and experience in SAP EHSM in Incident Management, Risk Assessment, Environmental...SeniorRegulatoryRemote jobLocal area
- ...plus. Familiarity with the Investment Advisers Act of 1940, Investment Company Act of 1940, ERISA, MIFID or other adviser related regulatory regimes. Good critical-thinking, research and social media tools familiarity is critical, as well as a sense of curiosity....SeniorRegulatoryRemote job
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr Associate Software Engineer - Regulatory Structured Submission. Be the first to apply!
