A pioneering biotechnology firm in Boston, MA, is seeking a Director of Vector Engineering to oversee the discovery strategy for novel lentiviral vectors. The ideal candidate will have over 8 years of experience in gene therapy R&D, strong leadership skills, and a proven track record in optimizing viral vectors. This dynamic role involves collaborating across teams and managing projects that have a tangible impact on patient outcomes, all within a supportive and innovative environment.
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$165k-219k yearly est. 4d ago
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Director, Global Tax Policy & Advocacy
Astrazeneca 4.6
Senior manager job at AstraZeneca
Typical Accountabilities
Contribute to the Global Finance function
Help execute the functional strategy for the Global Finance function in line with the Group Strategy
Support senior director in working towards short and long term goals that enable delivery of the overall Finance function strategy and which offer a compelling finance service proposition
Have clear understanding of business strategy across all SET areas coupled with an ability to tailor finance solutions in ways that ensure they drive performance and deliver business value
Support business executives (SET and Board) to ensure strong strategic contribution
Help manage key external stakeholders such as banks, regulatory authorities and tax authorities
Maintain effective and supportive Business Partnering relationships across SET areas to understand business plans and implications and so manage and where appropriate mitigate business risk
Support development of appropriate processes to deal with changing market/country demands
Work with governments, regulatory authorities and lobbyists to shape policy and legislation in a way that supports the goals of the global organisation
Coach and deliver effective performance to direct and indirect reports creating a supportive working environment where everyone has the opportunity to fulfil their potential
Instil a strong customer service and high performance culture with a focus on continuous improvement
Typical People Management Responsibility (direct / indirect reports)
Approximate number of people managed in total (all levels) -
Manager of a team
Global Remit
Own country
Education, Qualifications, Skills and Experience
Essential
MBA or other Finance/Business qualification
Extensive work experience in Finance Function
Qualified specialist finance professional
Significant post-qualification experience
Experience of working across a global organisation
In-depth understanding of regulatory/statutory requirements and governance principles/SOX
Experience of working with seniorManagement
Varied range of experiences in specialist Finance with specific expertise in related specialist area
Team leadership / management experience
Project Management
Desirable
Specialist financial qualification to support general financial qualifications
Key Relationship to reach solutions
Internal (to AZ or team): Finance Directors; Senior Finance Management Team; SET area VPs, ISMO CFO's; Finance Business Partners; Cross Functional Management Teams
External (to AZ): Government Departments / Agencies; External Auditors; Legal Advisors / Regulators; Banks; External Advisors with defined accountabilities
Compensation Pay Range
181,576.00 - 272,364.00 USD Annual
The annual base pay (or hourly rate of compensation) for this position is outlined above. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
05-Jan-2026
Closing Date
29-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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$170k-230k yearly est. 2d ago
Director, Global Strategic Market Insights (Remote)
Jazz Pharmaceuticals 4.8
San Francisco, CA jobs
Global Strategic Market Insights, Director
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include neuroscience and oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
Position Profile
The Director, Global Strategic Market Insights is an integral part of the Global Commercial Development & Planning team at Jazz Pharmaceuticals. The role supports decisions related to commercial assessments of our pipeline products and market planning including competitive readiness. The candidate should have significant experience with competitive intelligence, pipeline related market research, and scenario planning/opportunity assessments with an ability to develop and deliver a narrative to key stakeholders, decision makers.
Strong candidate attributes include strategic mindset, collaborator, creative problem solver, voracious learner, and a strong work ethic to join our team. The candidate should have experience working in the biopharma/ life sciences industry with a solid working knowledge of the industry.
The director will partner with various cross-regional, functional groups to drive alignment on key assumptions and collective point of view. S/he will construct and implement primary research/competitive intelligence to deliver critical objective insights, anticipated market movements, and inform recommendations and plans that best position Jazz in new and continuing markets.
This individual will work closely with others in numerous functional areas including but not limited to Global Commercial Development, Early/Late-Stage Development Teams, EU International groups, Commercial, Market Access, Medical Affairs, Global Forecasting, R&D, and Investor Relations.
Essential Functions
Partner with key stakeholder groups to support strategic and tactical decision-making with high quality, insightful analysis that accurately and objectively reflect the voice of our customers and market dynamics to maximize the potential of Jazz's current and future markets.
Lead global insights and assessments to support market opportunities and readiness
Participate actively in global commercial development planning efforts by providing objective, in-depth analyses on current and future markets, customers, and competitors. May be an active member on various teams.
Provide high quality insights on the market environment for relevant disease areas based on publicly available brand and market information, non-publicly available market intelligence, and market research.
Reinforce market research best practices - develop proposals, identify market research sources, vendor options, and methodologies that are best suited to address a business need. When appropriate, proactively challenge the design of research with internal team members and vendors to enhance strategic value.
Translate data and information into compelling insight stories. Frequently and proactively present research findings to promote awareness and action to drive business decisions, strategic plans.
Conduct commercial assessments and scenarios including researching key assumptions, uncertainties to support the forecast.
Lead global competitive analysis and intelligence to support competitive readiness
Provide objective competitive assessments and analyses to align teams and enable effective and informed decision-making. This includes insights on dynamic market changes (shifting standard of care, emerging agents/trends, platforms, opportunities) and competition that impact business decisions and strategy.
Stay abreast of competitive landscapes and determine CI needs (threat assessments, benchmarking, timelines, reporting/alerts, primary, workshops, etc.) which may include leading a competitive readiness team and associated activities.
Drive competitive intelligence planning and reporting for key congress with internal partners.
Strategic thought partner and subject matter expert who will serve as the go-to for competitor insights. Frequently and proactively share knowledge of key competitors to promote awareness and readiness into business assumptions, strategic plans.
For all areas of this role, it is imperative to formulate an objective narrative and to communicate / adapt it for various audiences including executives.
Required Knowledge, Skills, and Abilities
Eight to ten years of relevant experience in biopharmaceutical business strategy, market or competitive intelligence, consulting, or combination of relevant experience. Neuroscience and/or oncology experience is helpful.
Experience in operating in global markets is preferred, and experience in working across the whole lifecycle of the products (from early research through commercialization).
Candidate should have a successful track record functioning in a matrix environment and delivering results in the areas of market research, product analytics and/or forecasting, and competitive intelligence. Proven ability to lead a cross-functional discussion in an organized and thoughtful manner, systematically using supporting information and logic, building and defending cogent arguments. Prior experience interacting with seniormanagement highly preferred.
Fluency in understanding scientific and market data to identify patterns and opportunities. Broad experience in secondary and primary research methods and comfort with forecast and uncertainty modeling and methodologies.
Effective presenter and communicator.
Willingness to travel to various meetings/conferences including international travel subject to company and regional guidelines.
Required/Preferred Education and Licenses
BS/BA degree required; advanced degree in a life sciences related field strongly preferred (MS, MBA, PhD).
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$155k-220k yearly est. 5d ago
Senior Manager, Order to Cash
Vertex Pharmaceuticals 4.6
Boston, MA jobs
**Job Description****General Summary:**Vertex is seeking an experienced Order to Cash professional to join our Controllership organization as a seniormanager within the Global Revenue Accounting team. The Controllership organization is integral in delivering Vertex's mission of creating transformative medicines for people with serious and life-threatening diseases. You will be working as part of a dynamic and diverse organization alongside outstanding people who are forward-thinking, collaborative and recognized leaders in their areas.The position is a key role within Global Revenue Accounting, and we are seeking an experienced and strategic SeniorManager within Order to Cash “O2C” to manage our credit control function, drive cash flow optimization, manage internal controls and implement solutions that strengthen financial performance. The successful candidate will combine hands-on credit control expertise with strategic insight, leading a team of two to maximize collections, minimize risk, and support business growth.Central to this role is fostering exceptional working relationships across the Controllership function, Global Supply Chain, our third-party logistics providers, and regional finance teams. The individual will also be well organised, comfortable presenting and influencing senior stakeholders and able to manage competing deadlines.This role is highly visible across the international organisation and with our global head office in Boston and offers excellent opportunities for personal development and continuous improvement. As Vertex continues to grow, and expand geographically, the successful candidate will have many opportunities to shape processes and drive lasting change.**Key Duties and Responsibilities:*** Work with global finance, revenue accounting, trade ops, supply chain and market access teams to ensure we remain at the forefront of any changes to our ways of working* Implement and enforce credit policies and procedures that mitigate risk while supporting customer relationships* Present credit & collections updates to Senior Directors and Departmental Heads* Build strong relationships with our external service providers, internal stakeholders and business partners* Represent the team at Global Credit Committee meetings, interacting with the Global Finance and Chief Accounting Officer's leadership team* Develop and execute credit strategies that optimize cash flow, reduce Days Sales Outstanding (DSO), and minimize bad debt* Protect Vertex's credit risk with consideration for securitisation initiatives.* Design process solutions in support of key business decisions and new product/country launches* Drive improvements in our monthly Dashboard reporting* Drive transformation initiatives (system/process/policy)* Participate in global projects representing the needs and interests of the O2C and wider Revenue Accounting team* Analyse the performance of external service providers against KPIs* Ensure our ongoing compliance to all O2C related SOX controls**Knowledge and Skills:*** Ability to work collaboratively with external service providers, to ensure the highest standards of execution are maintained and the interests of Vertex and its patient remain forefront* Strong stakeholder management skills, able to quickly establish credibility and build effective, collaborative, working relationships at all levels* Excellent communication and interpersonal skills necessary for leading cross functional projects and presenting to seniormanagement (including accounting, finance and commercial management)* Ability to partner with other functional areas to develop, improve and monitor compliance with policies and procedures including taking a leadership role on certain initiatives* Strong financial analysis and reporting skills* Strong knowledge of credit control, risk management, and regulatory compliance* Strategic thinker with ability to provide solutions to cash flow and credit challenges* People management skills, with experience motivating and developing teams* Solution-focused with experience in improving processes and systems* Ability to pivot based on demand and prioritization**Education and Experience:*** Bachelor's Degree in Accounting or Business administration, or equivalent business experience* Strong credit control/accounts receivable experience, in a managerial or leadership role* Experience in large, complex, or multinational organizations preferred* Experience in pharmaceutical industry preferred#LI-SG1#LI-Hybrid**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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$131k-172k yearly est. 5d ago
Director, Global Market Insights & Strategy
Jazz Pharmaceuticals 4.8
San Francisco, CA jobs
A biopharmaceutical company in San Francisco seeks a Director of Global Strategic Market Insights. This role involves conducting market research and competitive intelligence to guide commercialization strategies. Candidates should have 8-10 years of relevant experience in the biopharmaceutical industry, with strong analytical skills and the ability to communicate effectively with stakeholders. An advanced degree is preferred, and the position may require occasional travel for conferences and meetings.
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$165k-224k yearly est. 5d ago
Director, Market Access Strategy (Heme)
Vertex Pharmaceuticals 4.6
Boston, MA jobs
Director, Market Access Strategy (Heme) page is loaded## Director, Market Access Strategy (Heme)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27384**Job Description**Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF), Sickle Cell Disease, Transfusion-Dependent Beta Thalassemia and Pain. In addition to clinical development programs in these commercialized areas, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases including programs in Type 1 diabetes, IgA Nephropathy (IgAN), APOL-1 Mediated Kidney Disease, and Duchenne Muscular Dystrophy, among others.The **Director,** **Market Access Strategy (Heme)** is accountable for leading, overseeing, and project managing the development of Market Access (MA) strategies, primarily the payer value proposition (PVP) resources and associated materials and trainings, tactical support programs and overall execution of access resources across all channels for the commercialization of CASGEVY. This role requires a significant degree of collaboration, leadership, influencing and driving strategic alignment across multiple functions (Account Management, Trade, Pricing & Contracting, US Public Affairs, HEOR, Global Value & Access Strategy (GVAS), and Marketing). This role will report into the Sr Director, Market Access Strategy, Heme.* Provide **critical leadership** and project management in developing and implementing **brand and market access strategies** by channel, to support patient access and customer reimbursement for CASGEVY via the creation and delivery of impactful market access resources to identified and prioritized accounts. This includes leadership with CRC submissions, reviews and responses.* Strong ability to **wholistically evaluate** Market Access Landscape, continue to generate **insights** to inform **strategy and execution*** Drive payer strategy including understanding of pricing, contracting, payer landscape, access & reimbursement to ensure all strategies and tactics are well thought through and aligned to overarching brand strategy* Refinement and execution of the market access strategy across Payer and Trade* Lead initiatives to understand, analyze and demonstrate clinical, economic, and societal value to payers, decision-makers, and influencers based on FDAMA114 guidelines (aka Pre-approval Information Exchanges) as well as payer value proposition* Develop, train, and implement the necessary promotional resources and reimbursement pull-through that support field account teams' efforts with key customers* Plan and execute payer Advisory Boards* Customize strategies based on Commercial, Medicaid & Medicare demographics, legislation, & trends* Maintain a strong understanding of the CASGEVY patient journey, billing and coding requirements and be a strong partner to the Market Access Strategy lead for the Access and Reimbursement field team.* Maintain a strong understanding of CASGEVY Trade policy and decisions, and work hand in hand with the trade strategy partners and trade account team to support our trade partners for an efficient and effective patient journey* Identify and address key product barriers to payer access and performance by applying advanced payer analytics and market trends* Primary point of contact overseeing agency and external vendors to deliver resources and strategic insights on time and within budget* Developing KPIs and metrics to assess impact of key initiatives* Act as trusted, subject matter expert on US market access landscape to internal colleagues and external customers**Knowledge and Skills:*** Expert knowledge of US healthcare system, including gov't & commercial payers (Medicaid experience preferred), policy, and regulatory environment* Strong experience working with National and Regional payer account teams aligning on **policy language, and operationalization of payer processes*** Strong understanding of the **hospital setting**, billing and coding requirements for therapies as well as the flow of funds coupled with **cell & gene experience*** Previous contract strategy leadership experience in the pharmaceutical/biotech or healthcare industry* Experience in developing and articulating a clear and pragmatic value proposition* Proven track record of meeting or exceeding objectives & goals, both as an individual and as part of a team* **Excellent communication skills** with experience presenting to customers and internal leadership* Demonstrated ability to **successfully lead cross-functional teams,** influencing without direct authority, with the interpersonal skills to foster collaboration and succeed in a highly matrixed environment* Ability to perform in a ***fast-paced environment***, manage multiple priorities simultaneously, and work effectively across cross-functional teams**Education and Experience:*** Bachelor's degree in relevant field. MBA or Advanced degree preferred* Typically requires 10+ years of MA experience or the equivalent combination of education and experience**Location**: HQ on a hybrid schedule (3 days a week)**Pay Range:**$201,200 - $301,800**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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$201.2k-301.8k yearly 5d ago
Director, Market Access Strategy - Heme (Hybrid)
Vertex Pharmaceuticals 4.6
Boston, MA jobs
A leading biotechnology company is seeking a Director of Market Access Strategy focused on Heme. This role involves developing market access strategies, collaborating across teams for effective payer solutions, and ensuring reimbursement for CASGEVY. Candidates should have over 10 years of experience in Market Access and a strong understanding of the US healthcare landscape, with excellent project management skills. The position is hybrid, allowing for flexible remote work.
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$158k-206k yearly est. 5d ago
Senior Director, Global Development Financial Planning & Analysis
Vertex Pharmaceuticals 4.6
Boston, MA jobs
**Job Description**Vertex is growing at a rapid pace with challenging and exciting opportunities for motivated professionals who are keen to contribute to the Vertex mission to invest in scientific innovation to create transformative medicines for people with serious diseases. Our robust and complex R&D pipeline requires a focus on efficiency and prioritization as we scale. The Vertex finance function is integral to achieving our company's strategic goals, providing critical insights and analysis in support of decision-making across the organization. We are investing in our ability to provide data-driven insights by organizing and automating financial data and processes to enable our growing global scale. We are also leveraging best practices to strengthen our business partnering and decision support capabilities. By joining our function, you will become part of a fast-moving, forward-thinking team to support the ongoing growth of a leader in the biotechnology industry.**General Summary:**The Senior Director, Global Development FP&A is a seasoned finance leader who partners directly with our Global Clinical Development (early- and late-stage programs) organizations and cross-functional program teams to run global financial planning, forecasting, and strategic analysis. Reporting to the VP of R&D Finance, this highly visible role serves as a strategic advisor to the Chief Medical Officer's organization and senior leadership, influencing portfolio prioritization and investment decisions through financial insights. The ideal candidate brings deep expertise in clinical trial finance, executive presence, and a proven ability to drive business outcomes in a dynamic, science-driven environment.This role is for you if you possess strong decision support analytical skills, project management expertise, team management skills, and demonstrated ability to collaborate with cross-functional teams to drive innovation and deliver successful product development outcomes.**Key Duties and Responsibilities:**A key leader in financial planning and analysis within our function, your responsibilities entail:Advanced Scenario Planning and Risk Analysis:* Build, maintain, and own clinical program-level budgets (Phase 1 to Phase 3), clinical trial cost models, and forecasts; produce cost-to-complete and cost per patient analysis used in strategic decisions.* Lead advanced scenario modeling for clinical programs, including sensitivity analyses on timelines, enrollment rates, and regulatory milestones to inform go/no-go decisions.* Translate clinical development plans into financial implications and ROI-based recommendations.Strategic Influence and Business Partnership:* Participate in cross-functional program teams and governance committees, providing real-time financial guidance.* Deliver program dashboards, KPIs and trend analyses for executive and portfolio reviews.* Prepare and present executive-level updates.Team Leadership:* Lead and develop a team of 6-8 clinical finance professionals: set team priorities, establish processes, and build scalable operating mechanisms for financial support* Drive automation and digital transformation of clinical finance processes, leveraging tools like Hyperion, Oracle, and emerging analytics platforms to improve accuracy and scalability* Mentor staff on forecast accuracy, stakeholder management and financial modeling best practices* Drive a collaborative, service-oriented culture between finance and Global Clinical Development organizations Governance and Compliance Leadership:* Oversee month-end and quarter-end close activities related to clinical expense (accruals, reconciliations, GL review).* Ensure accurate, timely accruals for CROs, FSPs, sites, labs and other clinical vendors. Maintain audit-ready documentation for clinical program spend* Improve transparency and accountability around clinical opex and resource allocation through clear processes, benchmarks and metrics**Basic Requirements:*** Bachelor's degree in finance, Accounting, or related field; MBA or CPA/CFA strongly preferred.* 12+ years of progressive FP&A experience, with at least 5 years in the pharmaceutical or biotech industry.* Experience supporting R&D or Clinical Development functions at a global scale.* Strong understanding of R&D processes, portfolio management, and project evaluation methodologies.* Proven ability to manage complex budgets, forecasts, and analyses in a dynamic, fast-paced environment.* Excellent communication and presentation skills, with the ability to influence stakeholders at all levels and a proven ability to present complex financial insights to senior stakeholders.**Important Knowledge and Skills:*** Deep understanding of pharmaceutical industry dynamics and executive-level business partnering.* Hands-on exposure to clinical operations and/or CRO/FSP budgeting.* Strong analytical capabilities in portfolio analysis.* Proficiency in Microsoft Office and financial systems, including Hyperion and Oracle.* Proven ability to lead change in complex, cross-cultural matrix environments.* Exceptional communication and influencing skills across senior leadership and cross-functional teams.* Ability to apply broad market knowledge to drive financial performance and strategic outcomes.* Strategic thinker with attention to detail.#LI-DB1#HYBRID**Pay Range:**$212,000 - $318,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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$212k-318k yearly 1d ago
Director, Patient Services Analytics
EPM Scientific 3.9
Boston, MA jobs
Greater Philadelphia or Boston (on-site 3 days a week)
A rapidly growing, Specialty Pharmaceutical company with a recent successful launch is seeking a Patient Services Analytics leader as a crucial addition to their Commercial Operations team. This individual will own the analytics strategy and execution for Patient Services, partnering closely with Trade, Reimbursement managers, Market Access, and Sales teams.
This high visibility position will drive the creation of standardized KPIs and dashboards, integrate specialty pharmacy data, and deliver insights that enhance speed
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to
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approval, conversion, adherence, and the overall patient experience.
Responsibilities:
Set the analytics strategy and roadmap for Patient Services, aligning standardized KPIs and definitions to business priorities and streamlining how insights are shared with stakeholders.
Oversee KPI and dashboard governance from intake and design through validation, deployment, change control, and access-ensuring consistency across field teams, hubs, vendors, and digital partners.
Lead patient‑journey and program performance analytics to measure throughput, cycle times, conversion, adherence, and abandonment; identify bottlenecks and recommend targeted interventions.
Drive advanced analytics, data integration, and cross‑functional leadership by developing predictive models, defining BI/data requirements.
Managing vendor/offshore resources, and translating insights into clear executive‑level narratives while maintaining compliance with Legal/Privacy.
Qualifications:
Bachelor's degree required, advanced degrees are preferred.
8+ Years in within the pharmaceutical industry, focusing on Patient Services/HUB Analytics.
Expertise in HUB & Specialty Pharmacy Data, case manager/reimbursement workflows, and exposure to specialty distribution data.
Fluency in Python, SQL, and hands-on experience with PowerBI/Tableau (demonstrating dashboard ownership and training).
Proven ability to lead teams, communicate technical data with stakeholders and cross functional departments, and manage external vendors.
Note: Applicants who do not meet the above requirements will not be considered for this role.
$118k-172k yearly est. 2d ago
Director, Commercial Assessments and Strategy
EPM Scientific 3.9
Philadelphia, PA jobs
Location: Philadelphia, PA or Boston, MA (**Candidate must reside within 50 miles of either location with 3 days on-site required)
EPM Scientific is partnered with a rapidly growing, Commercial-Stage biopharma to hire a Director of Commercial Assessments and Strategy. This individual would play a key role in leading business development, asset acquistion, and pipeline research.
If you have an entrepreneurial spirit and thrive in a fast-paced environment with hyper-intense growth, this could be the opportunity for you!
Responsibilities:
Assess growth opportunities by evaluating external assets, new indications, and adjacent markets to identify strategic fit
Perform research, build forecasts, and create valuation models to estimate market potential and guide prioritization
Apply clinical and scientific expertise to interpret data and shape recommendations for leadership
Work across functions to align perspectives and contribute to due diligence and competitive intelligence efforts
Qualifications:
Bachelor's degree required, advanced degree (PhD, MBA, etc.) strongly preferred
12+ years minimum experience within biopharma required
Strong experience in market research, forecasting, and analytics (industry and/or consulting)
Expert in extracting actionable market insights from large datasets
Proficiency in data visualization and presentation tools
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
$122k-170k yearly est. 4d ago
Senior Director, Commercial Patient Hub Data Operations
EPM Scientific 3.9
Philadelphia, PA jobs
Job Responsibilities:
Develop and manage patient hub data operations: Design and maintain data strategies, systems, and processes for patient support programs, ensuring accurate integration and stewardship of data from multiple sources.
Ensure governance and compliance: Implement frameworks to meet regulatory and contractual requirements, collaborating with legal teams on data usage, sharing, and retention policies.
Drive operational excellence: Oversee data pipelines, manage exceptions, and maintain accurate KPIs related to patient access, therapy initiation, adherence, and case resolution.
Lead teams and vendor partnerships: Direct cross-functional data teams and manage relationships with service providers, integration partners, and CRM vendors.
Enable analytics and insights: Deliver curated datasets and dashboards to internal stakeholders, partnering with analytics teams to generate actionable insights on patient access and program effectiveness.
Experience:
15+ years in data management, commercial operations, or analytics within pharmaceutical/biotech industry.
7+ years leading data development and operations for patient services hubs, specialty pharmacy, or commercial data ecosystems.
Proven success building hub data operations in an insourced or hybrid operating model
Technical Skills:
Expertise in CRM platforms (Salesforce/Veeva), data integration (ETL/ELT), and BI tools (Power BI).
Knowledge of data tokenization (Datavant, IQVIA OCE), MDM, and interoperability technologies and standards.
Note: Applicants who do not meet the above requirements will not be considered for this role.
$94k-136k yearly est. 2d ago
Director, Global Engineering Strategy and Planning
Allergan 4.8
Greenlawn, NY jobs
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
Job Description Purpose
Provide leadership for the capital planning and strategy development aspects of the Global Engineering function. This includes leading the development of ongoing capital investment strategy for the global manufacturing network (IME) and oversight of the capital planning processes for all AbbVie operations. Lead engineering Front End Planning (FEP) activities in support of network strategy development including asset utilization modeling, capital cost estimation, business development deal input, pipeline technology assessment and network scenario development. Provides leadership for and ownership of all capital planning processes within Operations supporting the major financial cycles (Long Range Planning, Annual Plan, Update) to ensure optimal use of Operations capital. Provide recommendations to IME senior leadership on investments to optimize the manufacturing network footprint while maintaining assurance of supply and geographic balance. Remain abreast of emerging technologies and the state of the industry to inform network LRP strategy. Establish and maintain appropriate relationships with external engineering, architectural and peer organizations to facilitate benchmarking and incorporation of best practices into Global Engineering business processes. Provide project management, direction and oversight to the Global Engineering Programs department. Coordinate facility and utility projects to ensure adherence to AbbVie standards and specifications. Develop resource plans for approved projects and make recommendations regarding use of internal or external resources for project/facility planning, design and execution. Manage and leverage common engineering systems.
Responsibilities
Lead experienced team of project engineers in scenario development and capital cost estimation for projects ranging from $1MM - $200MM.
Accountable for all processes, policies and procedures related to capital planning.
Responsible for Operations-wide capital planning processes for all financial cycles (LRP, Plan, Update) with an annual investment spend of >$400MM.
Responsible for asset utilization modeling and development of multi‑year investment strategies for a global network of 27 manufacturing sites.
Conduct and record benchmarking of capital cost estimation best practices within AbbVie and professional associations, A&E firms and other peer companies.
Lead and coordinate objective criticality scoring of site‑level projects to deliver network‑wide investment prioritization.
Establish and maintain relationships with senior Operations functional leaders (QA, Central Services, S&T, BTS, etc.) to support development of functional capital plans and provide engineering support.
Interface with sites (leadership and engineering) to assemble and maintain a library of capability and capacity information to inform investment decisions and strategy.
Build partnership with S&T/R&D to ensure network technology preparedness to support the pipeline and influence key decisions early in the product development lifecycle.
Qualifications
Bachelor's Degree in Engineering. Master's Degree in Management or an MBA preferred.
10‑15 years of experience in Engineering and/or Manufacturing Management.
Key Stakeholders
SVP, Internal Manufacturing and Engineering; Regional VPs Manufacturing; VP, Global Engineering
Additional Information
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
Equal Employment Opportunity
US & Puerto Rico only - to learn more, visit *************************************************************************
Reasonable Accommodation
US & Puerto Rico applicants seeking a reasonable accommodation can learn more at *************************************************************
#J-18808-Ljbffr
A global biopharmaceutical leader focused on developing innovative medicines for patients with serious diseases is seeking a SeniorManager, Project Management. This organization has a diverse portfolio in neuroscience and oncology and a strong pipeline of cutting-edge therapies. In this role, you will lead and support FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs, ensuring compliance and operational excellence. Responsibilities include managing regulatory documentation and submissions, coordinating cross-functional and vendor meetings, overseeing stakeholder materials, and providing strategic updates to senior leadership.
Key Responsibilities
Execute and manage U.S. FDA-mandated REMS programs through effective project management.
Prepare and coordinate REMS regulatory documentation, ensuring timely submissions and responses to FDA requests.
Lead internal and external REMS meetings, manage timelines, and follow up on deliverables.
Oversee development and updates of REMS stakeholder materials.
Maintain submission archives and documentation repositories.
Support senior leadership with presentations and project updates.
Qualifications
Bachelor's degree in a relevant field required.
4-6 years in the pharmaceutical industry.
2-3 years of experience with REMS preferred.
Minimum 2 years in pharmaceutical project management.
Strong proficiency in Microsoft Office Suite and PowerPoint design.
Excellent communication, organizational skills, and attention to detail.
Ability to work independently in a remote environment.
Note: This role focuses on Regulatory Project Management regarding REMS programs rather than Regulatory submissions.
$95k-130k yearly est. 16h ago
Import Sourcing and Project Manager
Linton Group 4.1
Pennsylvania jobs
Linton Group partners with leading brands to design, develop, source, manufacture, and deliver high-quality products at competitive costs. With a mission to empower brands to achieve their full potential, Linton provides tailored solutions for every client, focusing on innovation and manufacturing optimization. The company is committed to maintaining exceptional quality standards while reducing overall production expenses. Their team of experts brings in-depth knowledge and experience, building long-term partnerships based on trust and mutual success.
Role Description
This is a full-time, on-site role for an Import Sourcing and Project Manager located in Bala-Cynwyd, PA. The individual will manage product sourcing and supplier relationships, oversee Purchase Order fulfillment and quality control activities, and lead various projects to ensure effective sourcing and manufacturing processes. Responsibilities include participating in new and existing product sourcing, identifying cost optimization opportunities, ensuring quality control standards, managing supply chain operations, and analyzing data to support decision-making. Collaboration with cross-functional teams and suppliers to deliver projects on time and within budget is a crucial part of the role.
Qualifications
3+ years experience in international sourcing and Purchase Order process
Proven track record in Supplier Management and Procurement processes
Strong Analytical Skills to evaluate cost efficiency and data effectively
Proficiency in Purchase Management and understanding of procurement workflows
Proven ability to execute Project Management tasks, ensuring milestones and deadlines are met
Excellent communication, negotiation, and organizational skills in Mandarin and English (MUST HAVE)
Knowledge of import/export regulations and supply chain management
Bachelor's degree in Business Administration, Supply Chain Management, or a related field
Prior industry experience and proficiency with procurement software tools are preferred
What we offer
💲 SALARY: Competitive compensation package plus bonus
🌍 GLOBAL EXPOSURE: Work directly with international vendors, overseas teams, and global supply partners
☀️ PAID TIME OFF: Structured PTO policy supporting vacation and personal wellness
🩺 MEDICAL BENEFITS: 100% employee medical coverage; family group rates available
🧠 MENTORSHIP: Direct mentorship and hands-on training from the CEO
📅 WORK STYLE: 100% in-office at our Bala Cynwyd, PA headquarters
📍 OFFICE PERKS & LOCATION: Onsite fitness center (membership available for a fee), café, complementary parking, EV charging, and more - just 15-20 minutes from Center City Philadelphia with easy access from both the city and suburbs
💼 CAREER ADVANCEMENT: Opportunity to grow with the company as Linton continues to scale
About Linton Group
Linton Group is a rapidly growing small business based in Bala Cynwyd, Pennsylvania, providing high-quality sourcing, manufacturing, and supply chain management services across industries including Electronics, Pets, Toys & Games, Garden & Home Improvement, Apparel, Home, Kitchen & Dining, and Jewelry.
Our mission is to empower brands to reach their full potential by helping them optimize production, reduce costs, and maintain the highest standards of quality. We pride ourselves on being a trusted, consultative partner-delivering personalized service and innovative solutions tailored to each client's unique goals.
With just three years in business and continued rapid growth, Linton Group offers an entrepreneurial environment where high performers can make an immediate impact, work closely with leadership, and grow alongside the company.
The policy of Linton Group is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's race, color, gender, age, national origin, religion, citizenship status, marital status, sexual orientation, gender identity, transgender status, physical or mental disability, protected veteran status, genetic information, pregnancy, or any other categories protected by applicable federal, state or local laws. Linton Group is an Equal Opportunity Employer - Minority/Female/Disabled/Protected Veterans.
$80k-117k yearly est. 16h ago
Senior Manager, Reimbursement Access - West
Xeris Pharmaceuticals, Inc. 4.2
Chicago, IL jobs
The SeniorManager, Reimbursement Access will play a critical role in ensuring appropriate patient access to Xeris products by leading the Reimbursement Access team, shaping national access strategies, and supporting operational excellence across the function. The incumbent must have deep experience in reimbursement, patient access, and healthcare provider support services, and leadership experience that includes driving the execution of complex operations while developing a high performing team of Reimbursement Access Managers.
**Covers CA, WA, OR, NV, and ID** **including:** Los Angeles, CA: San Diego, CA; San Jose, CA; San Francisco, CA; Seattle, WA; Spokane, WA; Portland, OR; Las Vegas, NV; Coeur d'Alene, ID.
**Responsibilities**
+ **Team Leadership & Talent Development**
+ Identify, recruit, onboard, and develop a high-performing team of Reimbursement Access Managers (RAMs) across key geographies.
+ Provide coaching, mentorship, and performance management to drive effectiveness and professional growth.
+ Lead field-based access teams to execute patient support strategies that improve access and affordability for patients.
+ **Reimbursement Strategy & Execution**
+ Collaborate with Patient Access leadership to design and implement innovative reimbursement access strategies that align with product and company goals.
+ Analyze access barriers and develop field-based solutions to improve access to therapies for rare disease patients.
+ Partner with internal teams (Commercial, Medical Affairs, Legal, Compliance) to ensure alignment and seamless execution of access initiatives.
+ **Operational Excellence**
+ Assist in developing standard operating procedures (SOPs), metrics, and reporting tools to evaluate and optimize the effectiveness of the Reimbursement Access function.
+ Drive continuous improvement initiatives to ensure the highest standards of patient access and compliance.
+ Monitor and assess reimbursement trends, payer coverage, and changes in access environment; provide recommendations to senior leadership.
+ **Stakeholder Engagement**
+ Serve as a strategic liaison between internal stakeholders and field reimbursement teams to ensure market and patient needs are addressed.
+ Provide insights from the field to inform leadership decisions on payer strategy, patient affordability programs, and other access-related initiatives.
+ Represent the company at relevant industry meetings, conferences, and with key external stakeholders as needed.
**Qualifications**
+ Bachelor's degree in business, healthcare, or related field (advanced degree preferred).
+ Minimum of 7 years of experience in market access, reimbursement, patient services, or related pharmaceutical roles.
+ Prior leadership experience managing field reimbursement teams strongly preferred.
+ In-depth understanding of the reimbursement landscape including buy-and-bill, specialty pharmacy, payer dynamics, copay assistance, and HUB services.
+ Experience in rare diseases or specialty biologics/therapies.
+ Demonstrated ability to lead cross-functional initiatives in a fast-paced, entrepreneurial environment.
+ Willingness to travel (up to 30%) to support field teams and stakeholders.
+ Competencies: Leadership, Presentation skills, Written and Verbal Communications, Analytical skills, Problem Solving, Teamwork & Collaboration, Customer Service focus, Adaptability, Professionalism
+ A valid, US state-issued driver's license is required as occasional driving to client locations is a core requirement of this position.
+ Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
+ Ability to Travel up to 30%. Travel may include air and ground travel to HCP locations, and company meetings
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-REMOTE
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $130,000 to $220,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for commission and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Direct Employers Posting:** Los Angeles, CA: Seattle, WA; Portland, OR; Las Vegas, NV; Coeur d'Alene, ID.
**Job Locations** _US_
**Title** _Senior Manager, Reimbursement Access - West_
**ID** _2025-2168_
**Category** _Market Access_
**Type** _Full-Time_
$130k-220k yearly 60d+ ago
Senior Manager, Global Regulatory Affairs
Otsuka America Pharmaceutical Inc. 4.9
Little Rock, AR jobs
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
**J** **ob Responsibilities**
- Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
- Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
- Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Serves as the sponsor point of contact to the health authority.
- Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.
- Effectively manages and directs internal support staff and external consultants for assigned projects.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
- Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Assess and develop innovative ideas to move GRA department to address current and future challenges.
**K** **nowledge, Skills, and Competencies**
**K** **nowledge**
- Experience working in the pharmaceutical and/or healthcare industry.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
- RAC certification a plus.
**Skills**
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).
**Competencies**
See OPDC Competencies Chart (Level X)
**P** **hysical Demands and Work Environment**
Travel (approximately 20%)
See document Physical Demands and Work environment for further requirements.
**Education and Related Experience**
Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$150k yearly 60d+ ago
Senior Manager, Clinical Management (Early Phase)
Otsuka America Pharmaceutical Inc. 4.9
Little Rock, AR jobs
Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.
****
- Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.
- Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.
- Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
- Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.
- Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.
- Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
- Participate in forecasting study expenditures and resourcing needs.
- Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.
- Provide timely communication of any variances in budget forecast to the Director/Associate Director.
- Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
- Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.
- Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.
- Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.
- Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.
- Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.
- Represent Clinical Management in departmental and cross-functional initiatives, as assigned.
- Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.
- May have supervisory responsibilities including:
+ Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
+ Assuring compliance with departmental, SOP, compliance, and corporate training
+ Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
+ Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.
- Performs other duties, as assigned.
**Qualifications/ Required**
Knowledge/ Experience and Skills:
- Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations.
- Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).
- Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.
- Strong understanding of global regulatory requirements.
- Strong communication, organization, planning, analytical, problem solving, and people management skills.
- Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.)
- Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).
- Ability to travel up to 25%.
**Educational Qualifications**
Required:
- Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.
Preferred:
- Previous supervisory experience.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$150k yearly 12d ago
Senior Manager, Global Regulatory Affairs
Otsuka America Pharmaceutical Inc. 4.9
Phoenix, AZ jobs
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
**J** **ob Responsibilities**
- Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
- Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
- Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
- Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
- Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.
- Serves as the sponsor point of contact to the health authority.
- Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.
- Effectively manages and directs internal support staff and external consultants for assigned projects.
- Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.
- Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.
- Assess and develop innovative ideas to move GRA department to address current and future challenges.
**K** **nowledge, Skills, and Competencies**
**K** **nowledge**
- Experience working in the pharmaceutical and/or healthcare industry.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
- RAC certification a plus.
**Skills**
- Strong oral and written communication skills.
- Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.
- Able to successfully interpret and apply regulatory intelligence to work output.
- Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
- Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).
**Competencies**
See OPDC Competencies Chart (Level X)
**P** **hysical Demands and Work Environment**
Travel (approximately 20%)
See document Physical Demands and Work environment for further requirements.
**Education and Related Experience**
Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$150k yearly 60d+ ago
Senior Manager, Clinical Management (Early Phase)
Otsuka America Pharmaceutical Inc. 4.9
Phoenix, AZ jobs
Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.
****
- Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.
- Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.
- Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
- Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.
- Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.
- Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
- Participate in forecasting study expenditures and resourcing needs.
- Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.
- Provide timely communication of any variances in budget forecast to the Director/Associate Director.
- Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
- Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.
- Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.
- Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.
- Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.
- Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.
- Represent Clinical Management in departmental and cross-functional initiatives, as assigned.
- Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.
- May have supervisory responsibilities including:
+ Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
+ Assuring compliance with departmental, SOP, compliance, and corporate training
+ Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
+ Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.
- Performs other duties, as assigned.
**Qualifications/ Required**
Knowledge/ Experience and Skills:
- Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations.
- Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).
- Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.
- Strong understanding of global regulatory requirements.
- Strong communication, organization, planning, analytical, problem solving, and people management skills.
- Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.)
- Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).
- Ability to travel up to 25%.
**Educational Qualifications**
Required:
- Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.
Preferred:
- Previous supervisory experience.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$150k yearly 12d ago
Business Unit Inter
PCI Pharma Services 4.1
Rockford, IL jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Title:
Business Unit Intern
Department/Group:
**Project Management**
Location:
**Assembly**
_The hiring rate for this position is $20.00hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k)._
Execute documentation preparation for 24/7 production environment. Manage lot & expiration form creation, administrative planning tasks, and outbound finished goods shipments. Identify potential process improvements to improve efficiency.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Support cGMP documentation creation and transactions as it pertains to lot/expiration form creation, outbound finished good shipments, and inventory reporting Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
**Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
+ **Stationary Position:** From 1/2 to 3/4 of the day.
+ **Move, Traverse:** From 1/4 to 1/2 of the day.
+ **Operate, activate, use, prepare, inspect, or place:** From 1/4 to 1/2 of the day.
+ **Install, place, adjust, apply, measure, use, or signal:** Up to 1/4 of the day.
+ **Ascend/Descend or Work Atop:** None.
+ **Position self (to) or Move (about or to):** From 1/4 to 1/2 of the day.
+ **Communicate or exchange information:** 3/4 of the day and up.
+ **Detect, distinguish, or determine:** Up to 1/4 of the day.
On an average day, the individual can expect to move and/or transport up to 10 pounds
less than 1/4 of the day.
This position may have the following special vision requirements.
+ Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception
+ Ability to focus ☒ No Special Vision Requirements
**Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
+ Work is primarily performed at a desk and/or in an office environment for 3/4 of the day and up.
The noise level in the work environment is typically, moderate.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Required:**
+ Working toward Bachelor's Degree in related field.
+ College Level Math Skills
+ Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
+ Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
+ High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
**Preferred:**
+ Ability to effectively present information to various people as the job requires.
+ Ability to work independently and/or part of a team.
+ Ability to display original thinking and creativity.
+ Ability to hold oneself in a professional manner.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled