דרושים Associate Pricing & Quoting ב-West Pharma ב-United States, West Whiteland Township

• Provide strategic leadership and oversight to ensure regulatory compliance across the product lifecycle.
• Manage highly complex regulatory projects, including drug-device combination products.
• Drive pre-market and post-market regulatory initiatives for successful product commercialization and compliance.
• Collaborate with internal teams such as Research and Development, Clinical, QA, Operations, Commercial, Legal, and Finance to execute key projects.
• Manage and support regulatory personnel in accordance with West and government requirements.
• Assist with US, EU, and ROW clinical programs and regulatory approvals.
• Enhance cross-functional effectiveness and drive continuous improvement in regulatory and quality operations.
• Maintain an up-to-date understanding of health authority guidelines and regulations to shape future regulatory strategies.

• Bachelor's Degree In science, math, engineering, or related discipline required
• Master's Degree In science, math, engineering, or related discipline preferred
• PhD In science, math, engineering, or related discipline preferred

• Bachelor’s Degree with 10+ years; Master’s Degree/PhD 5-8 years regulatory/pharmaceutical experience required
• Experience directly interacting and presenting to project teams, customers, industry groups required

• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Excellent interpersonal, communication and listening skills.
• Knowledge of regulatory guidance documents and standards related to human factors, combination products, delivery system and design controls.
• Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Advanced degree

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Conducting Investigations:

• Investigate a wide range of issues, including harassment, discrimination, retaliation, ethics violations, and policy breaches.
• Gather evidence by interviewing complainants, witnesses, and others involved.
• Review relevant documents and policies to establish facts and determine outcomes.

Reporting and Analysis:

• Prepare comprehensive, factual, and well-documented investigation reports with findings and recommendations for action.
• Maintain accurate and confidential records of all investigative activities and case tracking.
• Analyze case data to identify trends, inform policy updates, and develop proactive strategies.

Auditing and Compliance:

• Conducts audits on site compliance to HR Policy as well as Employee Culture.
• Conduct regular audits of employee relations cases and documentation to ensure adherence to established procedures and legal requirements.
• Stay up-to-date on federal, state, and local employment laws and best practices.

Consultation and Guidance:

• Provide expert advice and consultation to HR, managers, and leaders on employee relations matters and appropriate disciplinary actions.
• Partner with Legal and Compliance departments to ensure consistent and appropriate handling of cases.

Process Improvement:

• Proactively identify opportunities to improve Employee Relations processes, policies, and tools.
• Develop and facilitate training for employees and managers on employee relations topics and conflict resolution.

Bachelor's degree in Human Resources or a related field and/ or five years of directly related experience, or equivalent experience.

• Minimum of 5 years of relevant experience Human Resources.

• Exceptional strategic thinking, problem-solving, and organizational skills.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate with senior leadership and legal counsel.

In this role, you will be the primary point of contact for all KRONOS-related inquiries. You will be responsible for providing comprehensive support and assistance across various administrative tasks to ensure accuracy, compliance, and efficiency. The role involves closely collaborating with HR managers, supervisors, and the payroll department to maintain precise and timely payroll processing. Additionally, you will participate actively in audits and system upgrades to enhance the overall effectiveness of the operations.

• Assist and support Kronos time and attendance system for sites.
• Help remediate issues related to time and attendance, including identification and correction of inaccurate records.
• Help troubleshoot Kronos issues with HR managers and supervisors.
• Interface with Exton Payroll Department.
• On a biweekly basis, assist in finalizing the Kronos data in preparation for payroll processing.
• Interface with contingency employee agencies for time-related support.
• Participate in audits to ensure legal and policy compliance.
• Provide Kronos training to managers and employees.
• Participate in testing of system upgrades and new software
• Assist in preparation of vacation payout calculations for terminated hourly employees
• Complete all Verification of Employment inquiries.
• Assist in review of data entry of hourly and agency employees in HR system.
• Serve as temporary backup other Kronos administrators.
• Assist in creating and maintaining Job Aides..
• Comply with government regulations and company policy
• Other duties as assigned

• High School or equivalent experience is required.
• 0 to 3 years of either HRIS or payroll system experience.

• Excellent communication and interpersonal skills
• Strong organizational and time management skills
• Detail Oriented
• Proficient in Excel
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

The Sr. Associate – Technical Sales is primarily responsible for the identification and qualification of new opportunities and leads to support the launch of Integrated Systems. Strong research and analytical skill sets will be utilized to conduct targeted market research and associated analysis to identify new potential customers and emerging trends. The role requires establishing new customers to West and driving value via understanding the customer pipeline and aligning the appropriate Integrated System product. Develop additional strategy to continue to expand the West reach with new accounts as well as continued enhancements or development of new processes to drive efficiency with all service models. The Sr. Associate – Technical Sales is a self-starter who possesses a natural ability to proactively chase new avenues for identifying and capturing new accounts to the West Integrated System portfolio as well as working with Business Development and Strategic Marketing on top of the funnel tactics. This person will quickly develop their ability to identify, manage, and grow new and existing business.

• Responsible for the Integrated Systems Platform sales, engaging with both customers and internal teams to drive strategic growth initiatives.
• Acquire and manage new business through prospecting conversion of leads with a focus on our Integrated Systems portfolio.
• Develop strategies to forge new relationships with prospective customers by uncovering opportunities through strong listening and interviewing skills, understanding their drug pipeline, and offering tailored solutions that align with their needs.
• Provide support for effective customer follow-up from webinars and other West events, and engage with customers through the leads process, collaborating with Marketing on product campaigns tailored to our customer portfolio.
• Perform data analytics for customer or platform portfolios to drive enhancements to product and service models in support of new accounts and how they will be appropriately serviced.
• Understand market trends including relevant competitors, technology and regulatory issues to keep customer informed
• Utilize all service platforms, manage customers, training of the customers, and optimizing the use of support systems as well as working with other departments to improve the overall service model to these new account

Bachelor’s degree in Bioscience, Biochemical. Chemistry, Engineering, Pharmaceutical or equivalent experience. MBA preferred

Minimum 5 years of relevant B2B technical sales experience in industries that require a high degree of technical knowledge and regulatory requirements

• Knowledge or experience with ERP tools like SAP with Sales and Distribution
• Experience in prefilled syringe products and/or services.
• Exhibit strong competency in sales process and strategic account planning by regularly achieving business results that accurately mirror or exceed forecast
• Ability to strategically prioritize and suitably adapt and improve on strategic approach as and when necessary to focus on high value and likely to win opportunities/accounts
• Demonstrates knowledge of market segment, trends and internal customer issues that may influence a customer's priorities, tactics, and business approaches. Remains current on competitors, new technology and regulatory issues to maintain West’s scientific leadership position in the market
• Anticipates risks and devises contingency plans to meet them. Understands situation from many perspectives and makes decisions accordingly.
• Resourceful and is comfortable in navigating through internal resources by collaborating cross-functionally and can utilize resources effectively.
• Working knowledge of MS Office
• Familiarity with CRM systems is a plus
• Previous experience with cold calls and/or developing strategies to connect with and onboard new customers is strongly preferred
• Natural ability to demonstrate creativity with innovative thinking to discover and implement enhancements to existing processes
• Customer-Focused Attitude: A customer-centric approach with a genuine desire to ensure customer satisfaction and build lasting relationships
  Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Self-Starter with ability to work independently in a global environment as well as in team settings for project and/or process specific needs
• Be aware of all relevant SOPs as per Company policy as they relate to the role covered by this Job Description.
• Fully compliant with the company’s safety and quality policies at all times.

• Work is performed in an office environment. Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures.
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities.
• Read and interpret data, information and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.

• Track pricing initiatives and their impacts on business outcomes.
• Analyze customer behavior based on historical transactions and develop insights into customer segmentation and West options.
• Work with Strategic Pricing Team to extract competitive information for pricing.
• Investigate competitor behavior and motivation based on publicly available information such as annual reports, published prices, press releases and develop insight into their price moves.
• Improve relevant price and product data quality by supervising and providing the auditing guidance for the price data and administration team.
• Support Global Sales with specialist pricing enquiries.
• Support development of convincing value proposition in collaboration with Market Unit and Product Management.
• Support development of and training for pricing and simulation tools, e.g., Value estimator / Value capture simulation / Exclusivity models.
• Participate in secondary research in market / competitors / customers as required.
• Front line Pricing support for Global Sales.
• Support Global Sales on customer calls where required regarding customer pricing and DAs.
• Management and usage of Global pricing rules for price setting and guidance.
• Management of the price conditions in SAP for the CPQ Global quotation tool.
• Provide CPQ training and front-line support to Sales.
• Manage the Annual Price Change activities.
• Support the continuous improvement of the API annual activity.
• Creation and change of customer pricing in SAP PS4 based on increases negotiated by sales.
• Creation and change of contracted customer pricing in SAP PS4 liaising with the Contracts Team.
• Support Global Sales with argumentation and pricing history for price increases.
• Maintenance of the API SharePoint Customer Price Update log.
• Manage with creation and change activities the pricing conditions in SAP PS4 in line with all audit requirements and policies.
• Support Quarterly Price Variance reporting in line with Sarbanes Oxley requirements for compliance.
• Manage and maintain Global material pricing in line with Global Pricing Strategy
• Support Pricing Strategy improvement projects by providing analyses and identifying opportunities at the product and customer portfolio level.
• Perform other duties as assigned based on business needs.

• Bachelor's Degree in Business, Science, or related fields or equivalent experience required
• Minimum 5 years in Sales, Marketing, Finance, or related functions required

• Experience in SAP
• Certified Pricing Professional (CPP)
• Analytical skills, ability to attend details with accuracy, comfortable and creative in translating qualitative information into quantitative data, skill / experience in translating complex information into digestible insights.
• Computer skills - adept at Excel with advanced functions and proficient in MS Office suite.
• Business Acumen, understanding of how a company makes money – costs, margin, profits, overhead, depreciation, etc.
• Understanding of industry structures, business models, competitive dynamics.
• Communication skills - communication with stakeholders in convincing manner, comfortable with disagreements and ability to use them as a source of insights.
• Intellectual curiosity, investigative approach to collect data when required data is not readily available.
• Desire to learn new ideas, different opinions, and innovative approaches from external and internal sources and desire to dig deeper to get the root causes of observations.
• Able to comply with the company’s safety and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures.
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities.
• Position operates in a professional office environment. May stand or sit for extended periods of time.
• Read and interpret data, information, and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze, and solve problems.

• Design and develop prototypes to advance West’s containment and drug delivery device portfolio, focusing on novel, disruptive technologies.
• Lead, plan and execute new product development projects through all phases with a focus on design, prototyping, and engineering testing
• Generate CAD drawings and engineering drawings that can be prototyped using 3D printing and other rapid prototyping equipment. Perform prototype testing/assembly and troubleshooting in early feasibility stages.
• Analyze and evaluate device performance to make well-reasoned strategic recommendations for design improvement that can advance product feasibility milestones to inform R&D decisions.
• Independently and collaboratively come up with design concepts for new or modification of existing drug delivery devices/ combination products to meet end-user and/or industry requirements.
• Write, implement, and lead bench studies, tolerance stack up analysis, materials specifications, and component specifications.
• Develop detailed timelines for ensuring engineering milestones are completed on time.
• Facilitate technology transfer of medical devices and combination products from early feasibility to commercialization.
• Solve complex technical challenges that arise on both internal and external projects using own judgement and collaboration and persevere when setbacks threaten project goals.
• Capture project outputs in appropriate format including technical reports, presentation slides, research posters, invention disclosures or as project requires.
• Operate effectively as a leader in assigned roles.
• Manage multiple projects and communicate technical findings to various audiences, including non-technical stakeholders.
• Work Independently and as a Team member with Integrity, Precision, Accomplishment, Motivational Ambition, Respect, and Inclusion.
• Complete all activities with the highest regard for our company and local site procedures for safety, and quality compliance.

• Bachelor's Degree in Mechanical or Biomedical Engineering required
• Master's Degree Mechanical or Biomedical Engineering preferred

• Minimum 5 years' Experience in the medical device or combination product industry.
• Previous experience using SolidWorks required.
• Experience in medical device design, mechanical and functional testing, and failure analysis required.
• Expertise with test gigs and method development, and execution required.
• Demonstrated ability to come up with novel design concepts and develop functional prototypes in medical devices required.
• Demonstrated knowledge of mechanical principles, early-stage feasibility testing, and scaling from prototype to pilot manufacturing required.

• Experience working with medical device suppliers.
• Experience in Human Factors for Medical Devices.
• Experience in design history file management.
• Familiarity with risk assessments (e.g., FMEA) and design controls for medical devices.
• Knowledge of testing methodologies specific to combination products.
• Experience scaling technologies early-stage feasibility to validation and manufacturing.
• Demonstrated technical experience in injection molding, complex assembly and packaging operations for medical device or combination product component manufacturing.
• Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives.
• Knowledge of applicable ISO, and USP standards for drug delivery.

• Read and interpret data, information and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Observe and interpret situations, analyze and solve problems.
• Must be able to deal with ambiguity, use timely decision making, understand sensitivity for IP protection, deliver concise presentations to high-profile conferences, understand strategic direction, make contributions to strategy formation, be reliable and have predictable attendance.

• Complete the quarterly financial forecast and annual budget for the quality and procurement functions using BPC, proactively identifying financial risks and opportunities.
• Use SAP to gather, analyze, and interpret financial data, ensuring accuracy for month-end closing.
• Prepare and present financial reports and insights to senior management and associates during quarterly town halls.
• In collaboration with the reporting COE, develop and maintain financial dashboards using Power BI for impactful insights.
• Assist in identifying and implementing opportunities for process optimization and cost reduction, and provide financial insights to support ongoing cost-saving initiatives.
• Perform ad hoc analysis as needed.

• Bachelor's Degree Accounting or Finance required

• Minimum 5 years experience in the field of Finance or Controlling

• Very good knowledge of MS Excel, SAP and BI Tools
• Manufacturing ERP experience and cost accounting principles
• Exceptional financial acumen including strong analytical, financial modeling, budgeting and forecasting skills
• Ability to work with complex data and to identify key problems
• Very good analytical skills as well as communication and presentation skills
• Strong internal customer service focus and good interpersonal skills and the ability to present concepts and results in a concise manner
• Proactive approach and solution-oriented thinking and acting