דרושים Sr Associate Technical Sales- Integrated Systems 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.

The incumbent will be a strong advocate of quality systems and quality culture with the drive, experience and knowledge to be able to provide mentorship and direction on best practices.

The position can be located at any West site and is not limited to Exton.

• Ensure success of assigned projects by overseeing all aspects of project planning, resourcing, communications, problem solving etc.
• Coordinate Quality Culture events and initiatives such as Quality Culture workshops, recognition programs, customer visits etc.
• Establish and lead cross-functional quality-related meetings to review and discuss performance, status and prompting necessary actions as required.
• Partner with L&D, HR and other relevant functions to drive improvements to employee onboarding and training.
• Partner and/or liaison with other West functional areas to drive optimization of processes and procedures and bring resolution to issues.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Report out on projects and initiatives to Executive and Senior Leadership as requested.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• All other duties as required.

• Bachelor's Degree or equivalent experience required
• Master's Degree preferred

• Minimum 8 years Quality or related experience required
• Experience in regulated industry such as pharmaceutical and medical device preferred
• Experience with SAP and MasterControl systems preferred

• Project Management skills, able to manage multiple projects across the globe
• Ability to to forsee potential problems and navigate challenges efficiently all while maintaining a strong focus on stakeholder requirements and project goals.
• Strong interpersonal skills and ability to communicate at all levels of the organization e.g. during Global townhalls etc.
• Ability to work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions
• Knowledge of cGMP, cGDP, relevant ISO standards and medical device/Pharma requirements
• Ability to adhere to all company safety and quality policies

• 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 customer visits and business development related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• 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 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

• 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.

• Develop strong, cross-functional relationships within West Pharmaceutical’s Integrated Systems Operating Unit to establish the FP&A team as a key strategic partner in decision making.
• Analyze month-end financial results, working closely with the accounting team to ensure accuracy and integrity of financial reporting and resolve any discrepancies.
• Collaborate with the Integrated Systems Unit leader and leadership team to support and guide short-term and long-range planning with comprehensive financial analysis and insights.
• Lead the execution of budget, forecast, and strategic plan models, ensuring precision and alignment throughout monthly, quarterly, and annual processes. Conduct variance analysis to aid in performance evaluation.
• Review and influence strategic investments through comprehensive analysis of capital project business cases and Project Expenditure Request (PER) models, ensuring alignment with business objectives.
• Ensure financial planning aligns with organizational goals by identifying key financial drivers, evaluating risks, and providing actionable insights to support informed decision-making.

• Bachelor's Degree in Finance or Accounting required
• MBA, CPA/CFA strongly preferred

• 10+ years supporting the budgeting, forecasting, and long-term planning for a global, publicly traded business

• Manufacturing industry experience
• Excellent technical and analytical skills in finance, forecasting, financial analysis, and budgeting.
• Understanding of business disciplines to develop, analyze and interpret financial data.
• Executive presence and experience presenting to senior leadership.
• Demonstrated ability to work in a team environment on a global basis.
• Strong influencing and change management skills.
• Present analyses and advocate recommended actions to a variety of audiences with self-confidence.
• Ability to multi-task, prioritize tasks, and drive projects to completion with tight timelines.
• Demonstrated ability to learn quickly when facing problems and ability to apply knowledge to new situations.
• Superior verbal, written and interpersonal communication skills.
• Ability to interact with all levels of the organization, including Executive leadership.
• Strong work ethic and integrity to handle confidential/sensitive information.
• Ability to make recommendations and decisions independently.
• Experience using tools and systems such as SAP HANA, Hyperion, PowerBI, SAP BI, Microsoft Office products etc.
• Ability to lead teams and build effective working relationships both internally and externally.
• Strong presentation, communication, and interpersonal skills.
• Self-starter and results oriented independent worker.
• Able to be aware of all relevant standard operating procedures as 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.
• Ability to comply with the company’s safety and quality policy at all times.

• Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• 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
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

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.