The Data Fluency Lead will act as core member of a team managing an enterprise commercial data & analytics platform supporting UCB's US pharmaceutical business. At UCB, we don't just complete tasks, we create value. * Identify gaps in UCB data, evaluate potential data sets close such gaps, enlist stakeholders to conduct data POVs and work with stakeholders Our Insight to Impact team leverages advanced technology and techniques to deliver sustainable impact and generates unique actionable insights that enable our stakeholders to best allocate UCB's resources to creating sustainable Patient Value. We are looking for a Data Fluency Lead to join us in our Insights to Impact team, based in our Smyrna, GA Headquarters UCB is a global biopharmaceutical company, focusing on neurology and immunology.$88k-116k yearly est.60d+ ago
Medical Affairs Head axSpA
We are looking for a strong medical leader to join as an axial spondyloarthritis (ax SpA) Global Medical Affairs Head - Rheumatology within our global Rheumatology Mission team, ideally based in our HQ office in Brussels but will also consider candidates that may be based in one of our key hubs (UK or US (Atlanta)) * Proactively engage and be a key contributor to the overall Immunology and Global Medical Affairs Leadership community within the organisation. He / she will play a key role in setting the therapy area (TA) global medical strategy and scientific communication strategy and will also proactively contribute to the overall cross-functional asset strategy, by translating science into value for patients, health care community and the organization, and will provide global medical strategic direction to the regional Medical Affairs Teams. This is a senior role of high strategic importance to UCB. The axial spondyloarthritis (ax SpA) Global Medical Affairs Head will provide senior medical & scientific leadership and expertise for the global ax SpA and wider Rheumatology (and Immuno-Dermatology teams).$51k-97k yearly est.57d ago
Quality Lead U.S.
UCB is a global biopharmaceutical company, focusing on neurology and immunology. Learn more about sustainability at UCB and how it is integrated into our business approach. At UCB, we don't just complete tasks, we create value. We are looking for a U.S. Quality Lead who will ensure compliance with pharmaceutical regulatory requirements, maintenance of the local quality system, and ensures the release of high-quality product to our patients to join us in our Commercial QA Operations, based in our UCB Headquarters in Smyrna, GA.$71k-94k yearly est.60d+ ago
Neuroscience Sales Representative - Roseville CA, Reno NV
Join Takeda as a Neuroscience Sales Representative where you will work to enhance Neuroscience product promotion efforts within your assigned territory.$72.4k-86k yearly4d ago
Global Safety Officer
**Major Duties & Responsibilities**
Internal & External Safety Expert
+ Provide PV and risk management expertise to internal and external customers
+ Safety expert for product
+ Maintain knowledge of product, product environment, and recent literature
+ Maintain PV expertise, and understanding of international safety regulations and guidelines
+ Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
+ Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
+ Provide strategic and proactive safety input into development plans
+ Support due diligence activities and pharmacovigilance agreements
Impact
+ Ongoing assessment of the safety status of the product
+ Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
+ Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
+ Management of product safety alerts
+ Ensuring the GPE position is well articulated to and understood by its internal and external customers
+ Establishment of credibility of GSO function and of GPE
Signal Detection and Assessment
+ Responsible for signal detection and analysis
+ Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
+ Identify and implement proactive safety analysis strategies to further define the safety profile.
+ Lead aggregate safety data review activities and coordinate safety surveillance activities
Impact
+ Signal detection and analysis
+ Development of safety action plans and implementation, as appropriate
+ Enable effective development of product safety
+ Enable appropriate risk management
+ Enable up-to-date risk communication (e.g. labeling)
Risk Assessment/Risk Management/ Benefit-Risk Assessment
+ Provide proactive risk assessment
+ Co-lead benefit-risk assessment with other relevant functions
+ Develop risk management strategies and plans and monitor effectiveness
+ Collaborate with Center of Excellence for Risk Management and Safety Epidemiology
Impact
+ Optimization of the product benefit risk profile
+ Development of REMS, Risk Management and Development Risk Management plans
+ Identification and implementation of risk mitigation or other corrective actions as necessary
+ Regulatory compliance
+ Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed
Submission Activities
+ Represent safety position in cross functional submission teams
+ Ensure generation, consistency, and quality of safety sections in submission documents
+ Write responses or contributions to health authorities' questions
+ Support preparation and conduct of Advisory Committee meetings
Impact
+ Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:
+ For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports
+ For marketed products: Response to health authority question/request for information, Core Safety Information updates, periodic reports
Report Writing
+ Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
+ Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.
Impact
+ Regulatory Compliance.
**Qualifications**
Knowledge and Skills
+ Excellent clinical judgment
+ Capability to synthesize and critically analyze data from multiple sources
+ Ability to communicate complex clinical issues and analysis orally and in writing
+ Able to develop and document sound risk assessment
+ Demonstrates initiative and capacity to work under pressure
+ Demonstrates leadership within cross-functional team environment
+ Excellent teamwork and interpersonal skills are required
+ Fluent in English (written and spoken).
Formal Education And Experience Required
+ M.D. Degree or equivalent.
+ For MD, Board Certified/Board eligible, or equivalent, is preferred
+ For M.D., minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.
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
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.$38k-59k yearly est.6d ago
Pre-Employment Partner
_BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd._$107k-245k yearly est.6d ago
Senior Medical Science Liaison - Neuroscience - Southwest (CA, AZ, UT, NV, HI))
+ Demonstrate advanced knowledge regarding Takeda disease areas and products as well as therapeutic area competitor landscape; analyze and interpret complex scientific information and disseminate to KOLs/HCPs in a compliant, fair-balanced, and non-misleading manner + Support Takeda-sponsored research and appropriately assist with facilitation of strategically aligned medical collaborative studies and investigator-initiated research processes The Senior Medical Science Liaison is a field-based, external customer-facing member of the US therapeutic area medical unit team, responsible for analyzing, interpreting and disseminating scientific data, acquiring and translating customer insights, fostering external expert networks, and compliantly connecting customers to Takeda in order to advance medical strategy and improve patient outcomes. + Identify and cultivate partnership opportunities between KOLs/HCPs and Takeda US Medical + Minimum of 2 years of experience as a field-based medical science liaison (MSL) in the pharmaceutical industry is required$130.2k-186k yearly15d ago
Managed Care Contracts Lead
* 5+ Years of demonstrated success in analysis, reporting, forecasting, actuary, and modeling, with preferred minimum of 3 years of pharmaceutical experience in Managed Care or Operations. You will assist in the development of managed care contract forecasts, develop and leverage contract perforance assessments, and participate in contract review. The Commercial Managed Care Contracting Lead under Contracts & Pricing will a Subject Matter Expert liaison to support the Market Access Account Management, Market Access Marketing & Strategy, and the Patient Value Units. We are looking for a Commercial Managed Care Contracting Lead who is intellectually curious, adaptable, and analytically strategic to join us in our Managed Care Team, based in our Atlanta office in Georgia, United States. Role may require up to 5 to 15% travel to existing UCB sites.$84k-120k yearly est.33d ago
Transplant Network Manager - Northwest
**The Transplant Network Manager (TNM)** is the primary contact for all aspects of Sanofi commercial business within a solid organ transplant (SOT) or bone marrow transplant (BMT) center. + Leads cross-functional coordination, matching specific Sanofi assets and capabilities with customer needs. + Ultimately, the TNM must provide an alignment between Sanofi capabilities and specifically identified customer needs that provides the maximum benefit to patients.$92k-119k yearly est.10d ago
Director, Patient Services Operations
Sanofi General Medicines is currently building a strong, experienced, and passionate patient support team to support the launch of Rezurock. This newly created role will be instrumental in building an integrated Patient Services capability for General Medicines, leveraging best practices across Sanofi and the industry to enable the growth of Rezurock and Tzield through the establishment of best in class patient and practice services in coordination with Specialty Pharmacy programs and data. This individual will be responsible supporting the operations of the entire Patient Services program, primarily focused patient and specialty pharmacy data integration, analytics and reporting in partnership with with Sanofi BOS and IT.$90k-122k yearly est.8d ago
Global Data Strategy and Foundations Head 1
The Global Data Strategy and Foundations Head is responsible for developing a long-term data and advanced analytics strategy that enables impact through deeply understanding available, cutting edge and future availability of pharmaceutical commercial data, and ensuring a clearly aligned and implementable plan which will use resources efficiently while delivering best in class insights. We are looking for a Global Data Strategy and Foundations Head who is data driven, analytical and excited to join us in our Global Integrated Insights and Analytics team, based in our Headquarters in Atlanta, US. The Global Data Strategy and Foundations Head will have 1 direct report.$108k-241k yearly est.11d ago
Global Project Head, Hema-Oncology
The Global Project Head for Early Stage Hema-Oncology Development is noted as the **primary clinical/project lead for early stage programs focused on hematological malignancies** . + Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps$57k-72k yearly est.16d ago
Global Head Insights, Epilepsy Hub
We are looking for a Global Head Insights, Epilepsy Hub to join us in our Insights to Impact (I2I GTM) team. * Ensuring that UCB increasingly maximizes the use of secondary data and achieves a healthy balance between running primary studies and leveraging data to generate insights. * Evolve the adoption and usage of (secondary) data and advanced analytics and evolve UCB to become a reference in the industry The Global Head Insights, Epilepsy Hub will be a coordinating insights partner for the Missions and manage business needs re-actively and pro-actively with foresight, i.e., discuss, challenge, and agree on insights needs, priorities, plans and investments. * Help to ensure that UCB achieves its strategic objectives by supporting fact-based decision making through data, analytics, and primary research projects * Ensuring that insights are not replicated, usage and interpretation is maximized, and allocation of resources is in line with the UCB priorities across the various global and regional stakeholders The role is based in Atlanta, GA$82k-120k yearly est.28d ago
Contract Operations Analyst
We are looking for a Contract Operations Analyst who is intellectually curious, a strong collaborator, and strategically analytical to join us in our Market Access & Affordability team, based in our Atlanta office in Georgia, United States. The Contract Operations Analyst will proactively analyze financial and operational data (pricing accuracy, disputed claims, and contract loads) from multiple sources. Role may require up to 5 to 15% travel to existing UCB sites. In this position you will work alongside UCB's management and business process groups internally and externally. The Contract Operations Analyst is also responsible to develop productive relationships with key external decision-makers, and group purchasing organizations.$39k-58k yearly est.20d ago
Regulatory CMC Scientist - Biologics
UCB is a global biopharmaceutical company, focusing on neurology and immunology. Learn more about sustainability at UCB and how it is integrated into our business approach. We are looking for a Regulatory CMC Scientist - Biologics to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK), Raleigh or Atlanta (US) or Toronto (Canada) offices. At UCB, we don't just complete tasks, we create value.$51k-75k yearly est.28d ago
Commercial and Medical Planning and Execution Lead - Rare Diseases
The Rare Disease Organization represents a tremendous source of UCB's future growth potential. We are building a culture of collaboration, accountability, agility and swift entrepreneurial action in Rare Diseases at UCB. The Rare Disease Organization is a team, filled with diverse colleagues who will lead UCB's future development in rare disease. * Develop sub-team budget under the RDO budget planning process provided to them; partner with and UCB finance representatives as needed$44k-67k yearly est.60d+ ago
Regulatory Science Lead
* Be responsible for all regulatory activities related to product development and marketing authorizations within their assigned U.S. region and is the primary contact point within UCB for any regional regulatory issues with the product and with designated health authorities. * Maintaining awareness of UCB and competitors' activities in the region and share potential impact these activities may have on the product development program. We are seeking a motivated Regulatory Science Lead to be an integral member of our Global Regulatory Affairs group located in our Raleigh, NC or Atlanta, GA offices. At UCB, our people are our experiences and achievements, our passion and drive.$68k-145k yearly est.60d+ ago
Patient Assistance Program Lead
At UCB, we don't just complete tasks, we create value. * Develop additional measures of customer satisfaction, engagement and value of new solutions offered as they are implemented to ensure KPIs are met and we are continuously evaluating the success of any new services and solutions offered by UCB. * Prepare and deliver updates related to affordability trends, socioeconomic drivers of support and ensuring UCB Patient Value Ambition is supported appropriately within PAP. * Improve and build upon established UCB services to create new solutions that provide differentiation for UCB, such as HUB, deductible and medication replacement programs. * Assume leadership of external (vendor) relationships to ensure alignment to UCB values and ethical standards. The Patient Assistance Program Lead will partner across the organization in building the financial and access focused solutions to ensure UCB patients have access to medication. * Assist in implementing additional solutions within UCB to ensure patient access to products and solutions and creating exceptional caring experience throughout the patient journey. UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are looking for a Patient Assistance Program Lead to join us in our UCB Cares team based in Atlanta, GA At UCB, patients are at the heart of everything we do and improving the patient experience in dealing with access and affordability issues is a pivotal part of this goal.$22k-29k yearly est.7d ago
Global Medical Affairs Lead Rheumatology
We are looking for a Global Medical Affairs Lead, Rheumatology to join us in our Rheumatology launch mission team, based in one of our hubs HQ, Brussels, Belgium; Slough, UK or Atlanta, US$25k-58k yearly est.47d ago
Head of Mito Disease Sales
Routinely shares such information with relevant UCB stakeholders, ie, Commercial Leaders. You will be responsible for leading UCB's small Ultra Rare sales force that specializes in supporting diagnosis and treatment of Ultra Rare Diseases, specifically mitochondrial disease and Tk2d. The Head of Sales, Ultra Rare Disease will be responsible for managing sales strategy and ensuring alignment for a small National US Rare Disease team of Account Executives (AE). We are looking for a Head of Sales, Ultra Rare Disease who has the brightest mind, biggest heart and is passionate about transforming the lives of those experiencing serious rare diseases to join our US Rare Disease team for this hybrid-based position out of our Georgia offices in Smyrna.$150k-243k yearly est.11d ago
