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At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.

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🔥 Senior Specialist - Device Quality Engineering (Remote)

Posted about 6 hours ago

📍 United States

🧭 Regular

💸 93500.0 - 158900.0 USD per year

🔍 Healthcare

🔧 Requirements

Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).
Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
Must be a technical expert, work independently, and have excellent interpersonal relationship skills with flexibility to adapt to fast-paced environment with changing priorities.
Ability to work in a matrix organization and effective written and oral communicator.

💡 Responsibilities

Provide guidance on medical device design controls requirements to product development teams and cross functional team members.
Contribute towards the development of Design History Files.
Support development of Device Risk Management as needed.
Participate on Organon teams supporting cGMP and quality issues related to pure medical devices and the device constituent of a combination product.
Work with the External and Internal Partners to ensure that effective and robust Quality Systems are in place.
Provide proactive support in training and coaching assigned sites to initiate quality improvements within Development, Operations and Quality.
Audit and approve DHF (Design History File) documentation for applicable regulatory filings, clinical supply, development, and design transfer qualification.
Ensure compliance with regulatory and Organon requirements. Evaluate deficiencies and assess impact on compliance status.
Contribute to developing/revising policy and procedures.
Support preparations for regulatory agency inspections with focus on relevant device regulations and Quality system requirements.
Remain informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards
Support the development of DHF (design history file) deliverables for medical devices.

Quality Assurance

Posted about 6 hours ago

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🔥 Associate Director QMS, Core Quality Systems (Remote)

Posted about 19 hours ago

📍 United States, GBR, MEX, PRT, BRA, ESP, BEL, NLD

🧭 Regular

🔍 Pharmaceuticals

🔧 Requirements

Degree in Life Sciences, Engineering, or a related relevant discipline.
Minimum of 8 years of experience in the FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site leading manufacturing and/or quality roles, or in Global Quality.
Demonstrated leadership in Quality & Compliance, with in-depth knowledge of global health authority regulations and requirements, and the ability to effectively translate and communicate these requirements.
Subject matter expertise in regulatory requirements and expectations for Medical Devices, clinical supply, commercialization, and/or validation topics.
Strong collaboration and cross-functional leadership skills to drive continuous improvement, promote knowledge sharing, and endorse best practices across sites and functions.
Excellent facilitation and project management skills, with strong verbal and written communication abilities.
Proven ability to lead and implement multiple projects/tasks simultaneously, managing competing and/or changing priorities effectively.
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
Proven ability to make and act on decisions while balancing speed, quality, and risk.
Ability to provide innovative ideas to improve quality and compliance, including seeking new information and external insights.
Capable of working and communicating effectively with all levels of the organization globally.
Proven ability to effectively initiate and drive change across a diverse and multi-functional organization.

💡 Responsibilities

Ensuring the end-to-end life cycle process for the QMS is well-defined according to quality system attributes, with a robust management system in place to monitor the process and address any gaps within QMS and specific to training.
Confirming processes are defined with adequate procedures, governance, and clear roles, responsibilities, and accountabilities.
Defining and supporting the installation of the organization and infrastructure needed to execute QMS processes.
Developing and maintaining metrics for ongoing evaluation to ensure the system functions as intended, is reviewed by appropriate management levels, and serves as a basis for continual improvement.
Collaborating across groups, functions, and divisions (OMS and ORD) to lead permanent inspection readiness activities, including executing gap assessments, tracking aligned gaps to resolution, and escalating risks to senior management.
Maintaining a robust inspection process that maximizes inspection success and minimizes non-conformances resulting from inspection findings.
Act as a liaison between QMS, learning development, Operational sites, and Functional area to ensure alignment with learning needs.
Design, deploy, and maintain QMS topics.
Gather input for the design, development, and implementation of the OMS QMS deployment strategy.
Lead cross-functional global teams in developing topics within OMS and interface with other chapters, topics, and stakeholders across the network as needed.
Collaborate with topic owners and subject matter experts to assess system performance and drive continuous improvement.
Ensure quality requirements are sound and compliant by leveraging insights, experience, and judgment to proactively enhance the company’s QMS.
Provide leadership and technical direction on regulatory requirements within the GMP/GDP environment.
Monitor global regulations impacting assigned topics to develop and maintain accurate interpretations of regulatory requirements per market, in alignment with QMS policies and procedures.
Identify, resolve, mitigate, or appropriately escalate any issues or delays in content development project execution, ensuring all targets are met on time, in full, and to quality standards.
Drive the development, implementation, and realization of permanent inspection readiness for assigned topics.
Conduct gap assessments to support Medical Device inspections by collaborating with subject matter experts, documenting findings, and tracking agreed-upon gaps to resolution.
Maintain tools to track progress for permanent inspection readiness and regularly communicate status to senior management.
Support the current EtQ business owners within the QMS with continuous improvement projects and activities associated with EtQ business owners’ responsibilities.

LeadershipProject ManagementCross-functional Team LeadershipCommunication SkillsAgile methodologiesWritten communicationComplianceTrainingQuality AssuranceRisk ManagementStakeholder managementChange Management

Posted about 19 hours ago

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🔥 Associate Director, Quality Management System Operational (Remote)

Posted 1 day ago

📍 United States of America

🧭 Regular

🔍 Pharmaceutical

🔧 Requirements

Degree in Life Sciences, Engineering, or a related relevant discipline.
Minimum of 8 years of experience in the FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site leading manufacturing and/or quality roles, or in Global Quality.
Demonstrated leadership in Quality & Compliance, with in-depth knowledge of global health authority regulations and requirements, and the ability to effectively translate and communicate these requirements.
Subject matter expertise in regulatory requirements and expectations for Medical Devices, clinical supply, commercialization, and/or validation topics.
Strong collaboration and cross-functional leadership skills to drive continuous improvement, promote knowledge sharing, and endorse best practices across sites and functions.
Excellent facilitation and project management skills, with strong verbal and written communication abilities.
Proven ability to lead and implement multiple projects/tasks simultaneously, managing competing and/or changing priorities effectively.
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
Proven ability to make and act on decisions while balancing speed, quality, and risk.
Ability to provide innovative ideas to improve quality and compliance, including seeking new information and external insights.
Capable of working and communicating effectively with all levels of the organization globally.
Proven ability to effectively initiate and drive change across a diverse and multi-functional organization.

💡 Responsibilities

Ensuring the end-to-end life cycle process for the QMS is well-defined according to quality system attributes, with a robust management system in place to monitor the process and address any gaps.
Confirming processes are defined with adequate procedures, governance, and clear roles, responsibilities, and accountabilities.
Defining and supporting the installation of the organization and infrastructure needed to execute QMS processes.
Developing and maintaining metrics for ongoing evaluation to ensure the system functions as intended, is reviewed by appropriate management levels, and serves as a basis for continual improvement.
Developing, maintaining, and continually improving the permanent inspection process for Medical Device inspections.
Collaborating across groups, functions, and divisions (OMS and Organon Research and Development) to lead permanent inspection readiness activities, including executing gap assessments, tracking aligned gaps to resolution, and escalating risks to senior management.
Maintaining a robust inspection process that maximizes inspection success and minimizes non-conformances resulting from inspection findings.
Under the direction of their manager, ensures the Medical Device inspection readiness process is upheld.
Design, deploy, and maintain QMS topics.
Gather input for the design, development, and implementation of the OMS QMS deployment strategy.
Lead cross-functional global teams in developing topics within OMS and interface with other chapters, topics, and stakeholders across the network as needed.
Collaborate with topic owners and subject matter experts to assess system performance and drive continuous improvement.
Ensure quality requirements are sound and compliant by leveraging insights, experience, and judgment to proactively enhance the company’s QMS.
Provide leadership and technical direction on regulatory requirements within the GMP/GDP environment.
Monitor global regulations impacting assigned topics to develop and maintain accurate interpretations of regulatory requirements per market, in alignment with QMS policies and procedures.
Identify, resolve, mitigate, or appropriately escalate any issues or delays in content development project execution, ensuring all targets are met on time, in full, and to quality standards.
Drive the development, implementation, and realization of permanent inspection readiness for assigned topics.
Conduct gap assessments to support Medical Device inspections by collaborating with subject matter experts, documenting findings, and tracking agreed-upon gaps to resolution.
Prepare inspection front room, back room, and subject matter experts for executing inspections related to Medical Devices.
Maintain tools to track progress for permanent inspection readiness and regularly communicate status to senior management.
Communicate the status and outcomes of Medical Device inspections to senior leaders.
Track and ensure follow-up actions resulting from Medical Device inspections are satisfactorily completed.

LeadershipProject ManagementData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsAgile methodologiesDocumentationComplianceExcellent communication skillsQuality AssuranceRisk ManagementStakeholder managementProcess improvementChange Management

Posted 1 day ago

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🔥 Sr. Specialist, Quality Management System Operational (Remote)

Posted 1 day ago

📍 United States

🧭 Regular

🔍 Pharmaceutical

🔧 Requirements

Thorough understanding of regulatory requirements for drugs, devices, biologics, including risk management.
Minimum five years prior site and/or Global Quality experience in FDA and or EU regulated pharmaceutical, vaccine, biologics, API manufacturing preferred.
Five to ten years of manufacturing and/or quality operation management experience (or equivalent) within an FDA and/or EU pharmaceutical, device and biologics environment.
Ability to accurately interpret and apply regulatory expectations to the QMS in a drug, device and biologics manufacturing environment.
Must have strong analytical skills to develop and recognize appropriate actions plans and how they will impact operations and compliance.
Must have strong project management skills.
Model behaviors consistent with Organon's Leadership behaviors, values, and culture.

💡 Responsibilities

Oversee and coordinate the development, revision, review, approval and posting of QMS documents to improve, enhance or deployment of new Topic material and own and manage an existing Topic that has been deployed.
Co-Lead or lead a team of quality professionals, under the guidance of the Chapter owner, for the design, development, and implementation of the OMS QMS deployment strategy related to applicable QMS chapters.
Lead cross-functional global teams developing content for the chapter, and interface with other chapters/topics, and stakeholders across the network as required.
Supports the preparation, review, approval and posting of all Quality Manual documentation including Core Requirements, Policies, Guidelines, SOPs, Quality Alerts, Quality Bulletins, White Papers, Best Practices, Flow Charts and Templates and Training modules.
Manage the QSC Workplan to prioritize document scheduling to optimize QSC workload and ensure triennial reviews are completed according to schedule.
Work with (sub-) topic owners and subject matter experts to assess system performance and drive continual improvement.
Monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures.
Help identify, resolve/mitigate, or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full and to quality.
Administrative management of Chapter COPs and SharePoint.

Project ManagementData AnalysisCommunication SkillsAnalytical SkillsComplianceQuality AssuranceRisk ManagementStakeholder managementProcess improvement

Posted 1 day ago

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🔥 Sr. Specialist, Quality Management System - R&D (Remote)

Posted 1 day ago

📍 United States

🧭 Regular

🔍 Pharmaceutical or medical device

🔧 Requirements

BS degree in Health Sciences and/or Healthcare Practitioner Certification that are relevant to R&D in the pharmaceutical and medical device industries.
Two to three years of experience managing change to standard operating procedures and/or vital records within the pharmaceutical or medical device industry.
Professional experience in pharmaceutical/medical device R&D and/or quality management systems.
Understanding of international standards and regulations pertaining to change control of procedural documents.

💡 Responsibilities

Contribute to and reinforce the standards for change control as applied to R&D procedural documents.
Monitor and manage change control records within the ETQ Procedural Documents module.
Ensure R&D records in ETQ are labeled with correct metadata prior to processing for approval.
Work closely with colleagues across R&D to ensure awareness of change control principles, training on core procedures and ETQ, and accountability for quality of change control records and execution against procedural requirements.
Monitor active change control records for completeness and timely implementation.
Collaborate with the Associate Director, R&D Procedural Documents Management, to develop and communicate training to R&D staff on principles and procedures for change control of R&D procedures.
Stay informed of internal and external changes to expectations for change control, as applied to management of procedural documents.

Communication SkillsAnalytical SkillsCollaborationProblem SolvingComplianceTrainingQuality AssuranceData modelingData managementChange Management

Posted 1 day ago

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🔥 Associate Director, Retail Accounts

Posted 5 days ago

📍 United States

🧭 Regular

💸 138200.0 - 234900.0 USD per year

🔍 Healthcare

🔧 Requirements

BS/BA degree.
Minimum ten years of combined Managed Care related experience (e.g., Customer Team Leader, Managed Care Marketing, Solutions, Planning).
Demonstrated business acumen and account management skills.
Broad and deep understanding of retail market, health care trends and policy, specialty pharmacy, and pharmaceutical distribution channels.
Strategic and tactical planning skills.
Consultative selling skills with clinical and scientific knowledge.
Project management skills.
Analytical skills to assess current and potential opportunities to maximize the trade channel.

💡 Responsibilities

Developing and executing a retail channel strategy through partner identification, contract management, and product lifecycle planning.
Account and business planning (strategic and tactical) by customer, based on product portfolio to support business units.
Collaborates with leadership and HQ personnel in the negotiation, execution and adherence to the Specialty Product Purchase Agreements within specialty pharmacies and specialty Group Purchasing Organizations/Management Services Organizations, as appropriate.
Accountable for individual account performance against strategic, financial, and product access KPI’s.
Collaborates with the customer team to identify and pursue areas of mutual opportunity based on better health outcomes for patients.
Responsible for negotiating, communicating and implementing stocking incentives with key customers in support of new drug launches to ensure that product is available to downstream customers.

Project ManagementCommunication SkillsAnalytical SkillsAccount ManagementNegotiation skillsSales experience

Posted 5 days ago

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🔥 Associate Director, Market Access Insights - REMOTE

Posted 5 days ago

📍 United States

🧭 Regular

💸 125400.0 - 213100.0 USD per year

🔍 Pharmaceutical

🔧 Requirements

At least five years of relevant experience in pharmaceutical market access contracting.
Relevant experience in Market Access contracting and data analysis or Pharmaceutical Sales or Marketing contract development, negotiation, or Project Management.
Strong analytical skills to identify issues and devise effective solutions.
Collaborative focus with a desire to support team goals.
Ability to prioritize workload and establish cadence for important deliverables.
In depth understanding of secondary data sources and pharmaceutical data assets; examples of use in storytelling to drive change.
Strong verbal and written communication skills.
Demonstrated capability to think strategically and make inferences based on available data.

💡 Responsibilities

Drive business reviews for contract and pricing policies, procedures, and practices to ensure alignment with value-added targets.
Lead evaluation of analytics and identification of insights for emerging trends and evolving markets across payer channels and contracted partner purchases.
Collaborate with internal/external teams to create and implement innovative solutions to measure pull-through of contracts in place with payers and providers.
Build and facilitate use of models that portray risk and opportunity in the market, using therapeutic and market knowledge to support proactive assessment of opportunities and risks.
Proactively analyze syndicated and internal data to excavate insights and provide tactical guidance to support MA&AM and Brand leadership meet goals.
Facilitate reviews of contract performance with contract owners and leaders from brands, operations, legal, account management, marketing, etc. to ensure meeting ROI and pull through expectations.
Analyze current processes and identify areas for innovation and enhancement.
Develop a standard communication plan and design standard business review templates for reports and insights deliverables based on KPI performance reporting by segment.
Ad hoc analyses as requested by MA&AM leadership team members, as approved by manager.
Communicate consistently with brand, payer brand marketing, senior leadership, legal, finance, and other HQ personnel to share insights and segment specific expertise critical to purposeful business decisions.
Collaborate with Business Intelligence teams to monitor and align market event insights for leadership messaging consistency.
Ensure compliance with the requirements of Federal/State healthcare programs and regulations impacting US Contract Operations.
Coordinate annual MA&AM annual goal process, identifying targets and tracking progress.

Project ManagementSQLBusiness IntelligenceData AnalysisExcel VBACommunication SkillsAnalytical SkillsAccount ManagementNegotiation skillsReportingMarket ResearchData visualizationStrategic thinkingFinancial analysisData modelingData analytics

Posted 5 days ago

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🔥 Director, Sales and Account Management - East

Posted 5 days ago

📍 United States

💸 185200.0 - 315100.0 USD per year

🔍 Women's Health

🔧 Requirements

Deep experience in life sciences commercial leadership defined by a track record in Sales and Account Management leadership, including leadership over customer-facing teams.
Ten plus years of management experience leading customer-facing teams.
First-line management experience.

💡 Responsibilities

Develop and lead field-based colleagues to motivate and energize the team; adjust to Regional needs, as appropriate, and drive commercial execution.
Maintain a deep understanding of a complex contraception and Women’s Health market, including reimbursement, procurement, and clinical dynamics.
Provide thought leadership, direction, and prioritization for critical Sales and Account Management activities including customer and account segmentation, approaches that improve provider competence and confidence, and performance measurement.

LeadershipPeople ManagementSalesforceCross-functional Team LeadershipStrategyCommunication SkillsMentoringPresentation skillsWritten communicationExcellent communication skillsProblem-solving skillsMS OfficeAccount ManagementNegotiation skillsVerbal communicationReportingTrainingActive listeningBudgetingCross-functional collaborationRelationship managementSales experienceMarket ResearchData visualizationTeam managementStrategic thinkingCRMFinancial analysisCustomer SuccessBudget management

Posted 5 days ago

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🔥 Director, Sales and Account Management - West

Posted 5 days ago

📍 United States of America

🧭 Regular

💸 185200.0 - 315100.0 USD per year

🔍 Life Sciences

🔧 Requirements

Deep experience in life sciences commercial leadership defined by a track record in Sales and Account Management leadership, including leadership over customer-facing teams.
Ten plus years of management experience leading customer-facing teams.
Experience leveraging CRM technology to drive business results.

💡 Responsibilities

Develop and lead field-based colleagues to motivate and energize the team; adjust to Regional needs as appropriate, and drive commercial execution.
Maintain a deep understanding of a complex contraception and Women’s Health market, including reimbursement, procurement, and clinical dynamics.
Provide thought leadership, direction, and prioritization for critical Sales and Account Management activities including customer and account segmentation, approaches that improve provider competence and confidence, and performance measurement.

LeadershipProject ManagementPeople ManagementSalesforceCross-functional Team LeadershipStrategyFinancial ManagementCommunication SkillsAnalytical SkillsCollaborationAgile methodologiesMentoringNegotiationOrganizational skillsPresentation skillsWritten communicationInterpersonal skillsNetworkingRelationship buildingAccount ManagementVerbal communicationReportingTrainingStrong communication skillsSales experienceMarket ResearchTeam managementStrategic thinkingCRMData analyticsData managementChange ManagementCustomer SuccessBudget management

Posted 5 days ago

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🔥 Director, Sales and Account Management - Central

Posted 5 days ago

📍 United States

🧭 Regular

💸 185200.0 - 315100.0 USD per year

🔍 Life Sciences

🔧 Requirements

BA/BS degree.
Deep experience in life sciences commercial leadership defined by a track record in Sales and Account Management leadership, including leadership over customer-facing teams.
Ten plus years of management experience leading customer-facing teams.
First-line management experience.
US-based strategy and execution experience.
Experience leveraging CRM technology to drive business results.
Demonstrated ability to attract, lead, and motivate a strong results-oriented team.
Demonstrated agility and ability to anticipate and respond to evolving internal and external dynamics.
Experience translating divisional or brand strategies into customer facing execution priorities.
Ability to develop both Account Level and Segment level strategies.
Experience in the buy and bill market.
Experience leading a large, geographically diverse team.

💡 Responsibilities

Develop and lead field-based colleagues to motivate and energize the team; adjust to Regional needs as appropriate, and drive commercial execution.
Maintain a deep understanding of a complex contraception and Women’s Health market, including reimbursement, procurement, and clinical dynamics.
Provide thought leadership, direction, and prioritization for critical Sales and Account Management activities including customer and account segmentation, approaches that improve provider competence and confidence, and performance measurement.
Drive attainment of Regional business goals and growth targets for promoted brands by directing Regional field-based execution, including a compensation design that aligns to those goals.
Foster relationships with key customers by maintaining an active presence in the field to inform customer-led priorities and opportunities.
Take a proactive role as activator of field-based execution that implements relevant Provider and Account Management strategies informed in collaboration with Marketing and Market Access colleagues.
Collaborate with functional partners to create alignment, focus, and priorities that inform resource allocation and decisions for the WHBU.
Provide a consistent leadership voice and clear direction to Regional field-based teams and headquarters colleagues based on active listening, ownership of the strategy, and a clear vision.
Attract, lead, and develop a strong, results-oriented, and diverse team with a high level of trust, empowerment, and psychological safety.
Proactively inform new ways of working through training, incentive compensation, and alignment structures to ensure optimal customer facing operations in a changing landscape.
Operate with a solutions orientation and exhibit a bias for action and accountability.
Orchestrate customer facing priorities and actions, and people priorities in collaboration with peers and functional partners.
Collaborate with other Sales, Account Management and Sales Operations leaders across the US market to identify synergies and foster an Enterprise Mindset.

LeadershipPeople ManagementSalesforceCross-functional Team LeadershipStrategyBusiness OperationsCommunication SkillsAnalytical SkillsCollaborationProblem SolvingMentoringNegotiationAccount ManagementReportingTrainingRecruitmentSales experienceMarket ResearchTeam managementStrategic thinkingCRMFinancial analysisChange ManagementCustomer SuccessBudget management

Posted 5 days ago

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