דרושים Sr Analyst Pricing Strategy & Surveillance 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).

• Drive program delivery for programmatic aspects of due diligence through post-integration
• Build and communicate a common methodology for delivery/reporting across all workstreams
• Manage workstream accountability across the organization, including into the C-suite
• Maintain focus of workstream leads on key value-drivers aligned to the core deal thesis
• Lead the program execution of transaction integrations across all functions to ensure delivery in partnership with Corporate Development and other key stakeholders
• Participate in pipeline review to provide insight into future M&A integration delivery needs, budgeting, strategy, and resource planning to achieve successful outcomes
• Provide and maintain recurring reporting and score-carding of functional and business unit performance against plans of record and IMO Project Plans
• Applies lessons learned from prior deals to continuously improve due diligence and integration planning practices
• Work within Corporate Development to build due diligence services to provide targeted insights, experience-based observations, and EBITDA and cash improvement opportunities to guide investment determinations
• Provide proactive decision support to executives and team members
• Present data to senior stakeholders and serve as point-of-contact for integration leaders at entities being evaluated / acquired
• Mobilize the internal resources and external partners to ensure effective and timely delivery
• Other duties as assigned

• Bachelor's Degree in Finance or Business Administration or equivalent experience required
• Master's Degree preferred

• Minimum 8 years of relevant experience required
• 4-6+ years of consulting or project management experience, ideally with direct exposure to M&A and integration planning / management required

• Experience collaborating with cross-functional project teams.
• Exceptional interpersonal skills, communication capabilities and the ability to influence multiple stakeholders with competing / conflicting interests.
• Capable of organizing information succinctly and communicating to all levels of an organization.
• Experience multi-tasking to lead and execute multiple projects in parallel.
• Strong presentation skills and ability to present material and complex matters in a succinct and organized manner
• Ability to think critically in tactical and strategic dimensions simultaneously.
• Demonstrated ability to effectively work across various functions in order to ensure deliverables are met against required timelines.
• Ability to prioritize tasks in real time and exercise judgment in high-stakes environment.
• Ability to quickly establish credibility, trust and support with both internal and external constituents.
• Strong ability to communicate effectively with leaders at the most senior levels within the corporation.
• Ability to interface effectively with all levels and functions both inside and outside of the organization.
• Able to comply with the company’s safety and quality policies at all times.

• Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms
• 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
• 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, tight deadlines, problem solve, and prioritize
• Ability to make work independently and sound decision making
• Observe and interpret situations, analyze and solve problems

• Use technical expertise to identify system, network, and application vulnerabilities, adjusting designs based on new threat data.
• Collaborate with Infrastructure and Application teams for security reviews, vulnerability assessments, and remediation.
Support the implementation of Next Generation WAN/LAN architecture across the enterprise.Configure, implement, document, and manage security tools including Network Security, Cloud Security, End-Point Security, SIEM, DLP, Email, and security awareness training.
• Conduct automated/manual vulnerability assessments and penetration testing, collaborating with teams on remediation.
• Work closely with SOC/NOC to meet performance indicators and mitigate threats/vulnerabilities, including Security Incident & Event Management and daily threat analysis.
• Monitor systems to enhance network performance.
Troubleshoot, resolve, and communicate networking issues to employees and management.Assist with disaster recovery procedures and test plans.Diagnose and resolve hardware, software, and other network/system issues, replacing faulty hardware as needed.
• Provide system support and maintenance per standards, Network and Cybersecurity Service Delivery model, West policies, procedures, and regulatory requirements.
• Help create and maintain system lifecycle documents including Policies, SOPs, and SOIs per West policies and procedures.

• Bachelor’s degree, Diploma or equivalent experience

• 8-15 years of relevant experience

Proficiency with security products such as firewalls, URL filtering, and virus protection.Deep understanding of network infrastructure and security, including SD-WAN, routing, firewalls, and cloud networking.
• Strong focus on providing cost-effective security solutions while staying updated on security threats.
• Exceptional communication skills to translate IT concepts for non-technical audiences.
• Experience with Linux/Windows operating systems, coding languages, and networking basics like switches and routers.
Familiarity with Microsoft Azure, Cisco Networking, Fortinet SD-WAN, and security tools like IDS/IPS and encryption.
• Ability to work globally in a virtual environment, managing multiple priorities with flexibility.
• Proactive work ethic, effective prioritization in high-pressure situations, and adherence to relevant company SOPs.

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.

In this role, you will be responsible for planning, organizing, and leading projects to support the development of new packaging systems and or components that enhance and preserve West’s high value products. The ideal candidate will drive technical projects, work with cross-functional development teams, and work with strategic suppliers to develop new packaging systems for West’s HVP offerings. You will act as a subject matter expert for system and component packaging and drive technical decisions which support West’s business objectives. Key responsibilities include project management, testing coordination and execution, specification / drawing development, Design History File (DHF) documentation creation and cross functional collaboration while engaging with various project teams and functional groups. As a Senior Engineer, you will be responsible for mentoring more junior engineers within the group and identifying innovative solutions to broaden West’s portfolio. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals
2. Work independently only with strategic guidance in the most complex situations
3. Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

• Technical packaging lead for Integrated Systems R&D efforts related to product design and development processes from conceptualization to commercialization.
• Engage with cross-functional teams that include R&D, Pharma Processing, Marketing, Regulatory, Quality and Supply Chain to develop new packaging solutions.
• Develop innovative packaging solutions to support business growth and to enhance West’s position as an industry leader in drug delivery.
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for development of new packaging solutions. Maintain effective communications and working relations with all external parties.
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories.
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Other duties as assigned.
• Maintain effective communications and working relations with all external parties.

• Education or Equivalent Experience: Bachelor's in Packaging, Mechanical, Materials, or Chemical Engineering, or related engineering discipline
• Master's degree preferred

• Experience: 5-8 years of experience in development of packaging, medical devices, or combination products
• Previous experience in packaging development of sterile barrier systems
• Experience leading technical projects from concept through commercialization
• Experience in working under requirements of Quality Management System in a regulated environment
• Experience in communicating complex technical concepts to customers and internal stakeholders

• Thorough understanding of global testing standards and regulatory requirements related to sterile barrier packaging
• Excellent interpersonal and written/verbal communication skills
• Working understanding and application of fundamental engineering principals.
• Strong technical writing abilities.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy and quality at all times.

• An expert with complicated techniques, equipment, and/or test methods.
• Actively evaluating and learning new industry technologies and techniques.
• Independently complete projects from initiation through completion.
• Able to perform instrument troubleshooting independently.
• Mentor associate scientist and scientist level analysts.
• Ability to effectively communicate technical information to internal and external customers.
• Actively participate in and complete all appropriate training tasks in a timely manner.
• Provide training
• Author work instructions, SOPs, and qualification documentation.
• Lead lab investigations, OOS, and OOT as required.
• Meet individual and departmental goals and metrics.
• Make rational and sound decisions at an individual level.
• Other duties as assigned.
• Adhere to established laboratory safety procedures.
• Follow required cGMP regulations and internal QA procedures.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Willingness to learn and apply new analytical techniques.

• BS in a relevant scientific field.
• Minimum 5 years in a related field and a cGMP environment.

• Experience with Liquid Chromatography Time-of-Flight Mass Spectrometry (LCMS-TOF)
• Working knowledge of Extractables and Leachables.
• Working knowledge of MassHunter software.
• Able to be aware of all relevant standard operating procedures per Company policy as they are related to the position covered by this Job Description
• Support and contribute to 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.

• Effective dexterity to operate objects, tools, or controls and reach with hands and arms.
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)
• Job-related activities that require a physical activity such as standing/standing in laboratory environment.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.