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ACADIA Pharmaceuticals Inc. Princeton, United StatesPlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. · Responsible for supporting the overall strategy and approaches within Medical Safety and supporting the PV management on scie ...
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Otsuka Pharmaceutical Co., Ltd. Princeton, United StatesPosition Summary · Leads product safety teams in all aspects of pharmacovigilance and risk management activities for assigned products both marketed and in development. Key activities include medical analysis and decision making for the development and maintenance of the Company ...
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The Dignify Solutions LLC Raritan, United StatesResponsibilities: · 1.Will be responsible for building and driving business transformation capabilities across Pharmacovigilance and pharma R&D benefit management value chain with market research · 2. Should be able to create roadmap, TCO, ROI model, blueprints, implementation ...
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Novo Nordisk Plainsboro, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
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Associate Manager
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Associate Director, Global Drug Safety
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Director Risk Management, Drug Safety
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ACADIA Pharmaceuticals Inc. Princeton, United StatesPlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. · The Director, Risk Management (RM) is responsible for overseeing the Acadia Risk Management System including the process for ...
Associate Digital Product Manager, Global Drug Safety and Pharmacovigilance - Princeton, NJ, United States - Genmab
Description
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Associate Digital Product Manager, Global Drug Safety and PharmacovigilanceWe're transforming the treatment landscape for patients with cancer and other serious diseases by combining deep antibody expertise with unique methods of scientific discovery.
We focus exclusively on antibodies, putting our deep understanding of disease biology and treatment targets to work using innovative antibody technology platforms.
At Genmab, AI and Digital Technologies are being developed, implemented, and utilized at a pace never seen before.Join Genmab as part of our IT & Digital Team and become a key player in revolutionizing antibody-based medicines for cancer and serious diseases.
We're at the forefront of merging deep antibody expertise with groundbreaking scientific discovery, focused on transforming patient care. Dive into the dynamic world of AI and Digital Technologies at GenmabAs an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
These digital products are crucial to enable Business to operate and efficiently manage our growing drug development and marketed drugs portfolio.
Ideally, you are an expert with excellent domain knowledge in above areas, coupled with robust experience in digital product management and delivery.
In this role, you will collaborate closely with Business to help define product vision and roadmaps based on business requirements and user needs.
You will standup and lead agile Product Oriented Delivery (POD) team(s) and be accountable for successful delivery and ongoing product evolution and operational support.
Your responsibility also includes defining and monitoring measurable Objectives and Key Results (OKRs) and Key Performance Indicators (KPIs), ensuring alignment with our strategic goals.
Using the Product Oriented Delivery (POD) model, ensure its success and application in the development/implementation and utilization of technology products across the value chain of Global Drug Safety and PharmacovigilanceBe accountable for full life cycle of products in your portfolio from concept to retirement. Product suite may include SaaS products as well as in-house custom digital products.
Collaborate with Business and IT&D stakeholders and SMEs to define product vision and roadmap aligning with organizational goals.
Drive the design, development/implementation, testing, deployment and ongoing product evolution and SLA-based operational support of high-quality products, implementing agile and DevOps methodologies for efficient delivery.
If product requires computer system validation, be accountable for the initial GxP implementation as well as revalidation/ongoing deliverables needed to maintain GxP compliance beyond initial releaseContribute to budget planning and allocation of resources for both product development and ongoing operational support.
Track and report on product performance, addressing any issues affecting quality or user satisfaction, and optimize processes for improved efficiency.
Collaborate with broader IT team as needed for successful road-mapping, delivery and supportManage multiple use cases/ products simultaneously, establishing processes for intake, assessment, and decision-making.
Coordinate with other Product Owners across Research and Development to manage dependencies.
Bachelor's degree in Computer Science, Engineering, Lifesciences. MBA or Master's degree in strategy, management, engineering or a related field preferred.
~ In-depth knowledge of Agile Software Development Methodology and related tools like Jira
~8+ years of experience as a product owner, product manager, senior business analyst in Global Drug Safety and Pharmacovigilance areas, with at least 3 years in a delivery leadership role.
~ Product Lead, or similar, role in SaaS GxP implementations and/or bespoke GxP digital products in a mid-sized biopharma or CRO
~ Experience working with GxP regulations and procedures around change management, periodic reviews, and internal audits.
~ Experience leading RFI/RFP processes for market scan, vendor evaluation and selection, in collaboration with Business and IT stakeholders and other crossfunctional teams
~ Solid understanding of regulatory guidelines and data standards is a plus
~ We value teamwork, diversity, and an inclusive, supportive work environment. At Genmab, diversity drives our success. You are a fierce believer in our rooted-in-science approach to problem-solving
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.
Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.
No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
Learn more about our commitments on our website.Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
