Endo Pharmaceuticals Inc Jobs
- 191 JobsSenior Manager, RBQM Operations (Risk Coordinator) - REMOTE
**Clinical Quality Management (CQM) at Takeda** Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. $130.2k-186k yearly4d agoAccess & Reimbursement Manager - NPS Enterprise - Detroit - Remote
The Detroit Enterprise Access & Reimbursement Manager is a remote/field-based role that covers parts of Michigan, Indiana, and Ohio. ARM will partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. The major city is Detroit. $136.8k-205.2k yearly6d agoAssociate Director, Clinical Quality Assurance (Remote)
+ Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. + Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. + Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. $143.5k-200k yearly8d agoDirector, National Account - Veterans Affairs
+ Establish team selling model and implementation with other internal Sanofi stakeholders and maintaining connection with preferred group purchasing organizations (GPO, PPN, PBG) and indirect channel partners (Wholesalers/Distributors) employed by the National Health System. This Director, National Accounts Veteran's Affairs (VA) will be the primary lead for the VA, Department of Defense (DOD), and TriCare. Assigned customers and partnerships developed have regional/national scope, significant market impact (both direct and indirect influence) and establish market access (supply and contract/pricing nationally) to Sanofi Vaccines products creating a platform to maximize vaccine sales within all customer segments. This position requires routine engagement with senior leadership from Sanofi Vaccines and assigned customers, high-level coordination with Sanofi Vaccines headquarters, field sales management, and external partners. A Director, National Accounts is responsible for achieving/exceeding sales and marketing objectives across the high dollar value/dose volume customers with strategic value (Wholesalers, Distributors (W/Ds), National Health Systems, Group Purchasing Organizations (GPOs), National Physician Buying Groups (PBGs), Pharmacy Purchasing Networks (PPNs), Long-Term Care, and Payers). The Director, National Accounts position develops and manages strategic partnerships, high quality B2B relationships, and contractual agreements with Sanofi Pasteur's high-value customers. Director, National Accounts will contribute to and lead special projects based on their market knowledge, market access, key customer responsibility, experience, and skill sets. $130k-165k yearly est.15d agoDirector, GCP Compliance - REMOTE
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** + Lead/drive development and implementation of compliance management for clinical trial delivery including quality event determination and documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed + Establish and lead proactive compliance framework for clinical trial delivery functions, overseeing direct reports and functional service provider resources; establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies. + Develop, lead and drive clinical trial delivery metrics and reporting including but not limited to training and CAPA completion compliance **_ACCOUNTABILITIES_** Proactive GCP Oversight + Establish, build and lead proactive compliance framework for clinical trial delivery functions, overseeing direct reports and functional service provider resources + Partner with R&D QA on GCP compliance strategy; collaborate and enable multilevel corrective and preventative actions with QA, Process Training and Digital Solutions, and cross functional clinical trial delivery functions + Establish, build and manage proactive compliance project management team to plan, implement, manage and report processes to determine adherence and understanding of ICH GCP requirements and Takeda processes + Provide near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes. + Identify, strategize and facilitate solutions to identified areas of concern with cross functional clinical trial delivery stakeholders GCP Compliance Metrics and Reporting + Establish key performance indicators for clinical trial delivery, leadership reporting and mitigation strategies to track process quality and compliance + Partner with clinical trial delivery functions, R&D QA and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities + Oversee direct reports and/or functional service providers on GCP metrics and analytics team + Develop strategy and implementation plan for development and maintenance of KPIs, metrics and dashboards to track process quality and compliance GCP Quality Liaison + Establish compliance GCP Quality Liaison network responsible for clinical trial delivery deviation and CAPA management including deviation determination, documentation, liaising with QA and managing & closing CAPAs; Report non-compliance as needed + Srategize and lead study teams and functional areas in CAPA definition for deviations, audits and inspections. + Manage CAPA reporting for clinical trial delivery and facilitate leadership review; work with functional areas to solve compliance gaps + Lead compliance and oversight for GCP Quality Plan; strategize and collaborate with R&D QA on next steps and actions **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** + _Bachelor's Degree or international equivalent required, Life Sciences preferred_ + _10+ years experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in clinical study management, including at least 6 years of line management experience_ + _Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams_ + _Strong strategic thinking, planning, execution, and communication skills_ + _Global/international experience required, including ability to collaborate with colleagues and staff in other locations_ + _Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development_ + _Health care business acumen with a comprehensive understanding of the pharmaceutical industry_ _Base Salary Range: $160-229K. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time_ _Off. The_ _final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience._ **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Massachusetts - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time \#LI-Remote $160k-229k yearly11d agoRemote- Statistical Project Leader
As a Statistical Project Leader, you will provide statistical leadership and guidance for clinical studies in one or more indications and will be accountable for methodological and statistical aspects of clinical development or medical affairs plans and subsequent deliverables. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. $180.7k yearly31d agoSales Specialist - Eye Care - Detroit / Ann Arbor - Remote
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. Job Purpose: The Sales Specialist is accountable for implementing the sales strategies for Novartis Ophthalmology products consistent with Novartis' compliance standards, as well as all applicable legal requirements for those key-targeted Health Care Providers (HCP's) within an assigned territory. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. The Sales Specialist works closely with other Novartis Commercial Associates to generate pull-through within local payers, community HCP's and Systems of Care. The Sales Specialist will pull-through access and drive utilization for approved Novartis Ophthalmology products with appropriate patients. Understands fully the assigned customers' product and business needs and works to meet those needs while adhering to all of Novartis company ethics and compliance standards. $130.4k-195.6k yearly41d agoPrincipal Scientist, Laboratory Technical Services-Microbiology
The Principal Scientist is responsible for planning, designing, and execution of LTS activities, and also leading technical project teams of Scientists and Microbiologists. The Principal Scientist, Laboratory Technical Services-Microbiology is primarily responsible for supporting the microbiology testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. $65k-95k yearly est.11d agoPrincipal Scientist, Laboratory Technical Services-Microbiology
The Principal Scientist is responsible for planning, designing, and execution of LTS activities, and also leading technical project teams of Scientists and Microbiologists. The Principal Scientist, Laboratory Technical Services-Microbiology is primarily responsible for supporting the microbiology testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. $65k-95k yearly est.11d agoSupervisor, Sterile Fill (Midnight Shift)
The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. $43k-79k yearly est.16d agoChemist III
The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. $53k-72k yearly est.60d+ agoChemist III
The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. $53k-72k yearly est.60d+ agoChemist I
The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. $53k-72k yearly est.60d+ agoQuality Associate Specialist, Product Release (Day Shift)
Location(s): Rochester, Michigan Supports one component of the Generics business, at Rochester, MI site. The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Job Title: Quality Associate Specialist, Product Release $39k-59k yearly est.20d agoQuality Associate Specialist, Product Release - Day Shift
Location(s): Rochester, Michigan Supports one component of the Generics business, at Rochester, MI site. The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Job Title: Quality Associate Specialist, Product Release $39k-59k yearly est.34d agoQuality Associate Specialist, Product Release - Midnight Shift
Location(s): Rochester, Michigan The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Supports one component of the Generics business, at Rochester, Michigan site. Job Title: Quality Associate Specialist, Product Release $39k-59k yearly est.34d agoQuality Associate Specialist, Product Release - Midnight Shift
Location(s): Rochester, Michigan Supports one component of the Generics business, at Rochester, MI site. The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Job Title: Quality Associate Specialist, Product Release $39k-59k yearly est.34d agoQuality Associate Specialist, Product Release - Midnight Shift
Location(s): Rochester, Michigan The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Supports one component of the Generics business, at Rochester, Michigan site. Job Title: Quality Associate Specialist, Product Release $39k-59k yearly est.35d agoCo-op, Package Engineering
Co-Op of Package Engineering at Rochester, MI supports everyday activities of the Package Engineering Department. $46k-57k yearly est.37d agoValidation Engineer I
Location(s): Rochester, Michigan Assigned Rochester, MI site. $65k-85k yearly est.38d ago
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Endo Pharmaceuticals Inc may also be known as or be related to ENDO HEALTH SOLUTIONS INC., Endo Health Solutions Inc, Endo Health Solutions Inc., Endo International plc, Endo Pharmaceuticals and Endo Pharmaceuticals Inc.