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Senior Manager Employee Relations jobs at Teva in United States, East Bradford Township

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East Bradford Township
13 jobs found
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Teva Senior Manager Employee Relations United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
אחסנת משטחים במערך האוטומטי (עבודה על מלגזה). מיון, רישום וקבלת סחורה במחשב על פי נהלים. ליקוט וביקורת הזמנות ללקוח. פריקת משאיות ומכולות. עבודה מול מחשב (Word, Excel, Outlook). סביבת העבודה...
Description:
How you’ll spend your day
  • אחסנת משטחים במערך האוטומטי (עבודה על מלגזה)
  • מיון, רישום וקבלת סחורה במחשב על פי נהלים
  • ליקוט וביקורת הזמנות ללקוח
  • פריקת משאיות ומכולות
  • עבודה מול מחשב (Word, Excel, Outlook)
  • סביבת העבודה בחלקה הינה חדר קור (טמפרטורה של 5 מעלות בממוצע) וחלקה משרדית מול מחשב
  • העבודה במשמרות ( בוקר/ערב)
Your experience and qualifications
  • חריצות, אחריות, אכפתיות, סדר וארגון ויכולת עבודה בצוות
  • נכונות לעבודה במשמרות –חובה (תתכן עבודת לילה לפי צורך)
  • נכונות לעבודה בשישי / מוצ"ש במידת הצורך
  • נכונות לעבודה בש.נ במידת הנדרש
  • נכונות לעבודה במאמץ פיזי ממושך - חובה (זאת בכפוף לתקנות הבטיחות בעבודה ובהתאם לנהלי הבטיחות שיוגדרו באתר). לשם כך על העובד להיות בעל כשירות פיזית וללא מגבלות רפואיות רלוונטיות.
  • ניסיון קודם בתחום הלוגיסטיקה / מחסן ממוחשב (עבודה בסביבה ממוחשבת ומסופונים) – יתרון! (יתרון לחברות לוגיסטיקה / תרופות)
  • אנגלית ברמה בסיסית – חובה
  • רישיון נהיגה - חובה
  • רישיון מלגזה – יתרון
  • בגרות מלאה – יתרון
Reports To
In process of validation

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10.11.2025
T

Teva Senior Vice President Head Global Innovative Medicines United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
Setting the overarching R&D Innovative Medicines vision and strategy across Immunology & Neuroscience. Managing and continuing to evolve the key decision-making forum – Integrated Development Committee (IDC) and associated tools...
Description:
Key Responsibilities
  • Setting the overarching R&D Innovative Medicines vision and strategy across Immunology & Neuroscience.
  • Managing and continuing to evolve the key decision-making forum – Integrated Development Committee (IDC) and associated tools and processes to support robust portfolio decision making.
  • Interface internally and collaborate with senior leadership team members across the R&D organization and across Teva.
  • Drive the expansion of Teva's portfolios through leadership in partnership with the busines development teams.
  • Interface externally with global key opinion leaders around scientific and clinical developments as they relate to drug development.
  • Communicate effectively with regulators; guide presentations to Advisory Committees and response to regulatory queries on products submitted for approval including milestone development meetings.
  • Develop and articulate Teva’s mission to diverse constituencies such as those at scientific meetings,in targeted peer reviewed publications and other important forums for the Company.
  • Coming up with creative ideas around clinical designs to improve timelines and decrease cost.
  • Generate the development strategy for compounds manage the execution of the development plan.
  • Optimize clinical trials against safety, cost, therapeutic efficacy and endpoint and accelerate the forward movement of pipeline compounds.
  • Ensure that all processes related to patient safety in the conduct of clinical trials are strictly adhered to; identify early signals for targeted events/outcomes and propose appropriate responses to such signals.
  • Managing matrixed teams, empowering the teams, guiding and giving direction to the teams. In short, the SVP should optimize their way of working.
  • Building a best-in-class innovative development organization by identifying, attracting, developing and retaining talent at Teva.
Experience and Key Competencies
  • MD or MD/PhD in a relevant biomedical or life sciences discipline is required.
  • Minimum of 15 years of experience in pharmaceutical or biotechnology R&D, with a strong track record in leading innovation-driven initiatives.
  • Proven leadership capabilities in managing high-performing, cross-functional teams in a global matrix environment.
  • Exceptional strategic thinking, communication, and stakeholder engagement skills.
  • A “Doer” with a results orientation. Establishes clear expectations and priorities; drives key initiatives to completion. Sets goals and consistently delivers the plan. Monitors progress and proactively addresses issues and obstacles. Flexible and creative problem-solving skills. Highly decisive and action­ oriented. A strong personal work ethic.
  • An enterprising leader and builder. Proven ability to lead key initiatives; motivates teams to work collaboratively to achieve objectives. Achieves organizational focus on key priorities. Provides clear direction, delegates, actively communicates. Superior project and people management skills.
  • A nimble strategist. Able to lead/contribute to strategic planning, based on a thorough understanding of industry trends and opportunities. Demonstrated creativity and effectiveness in addressing strategic challenges. Possesses an entrepreneurial mindset; capable of thinking out of the box and taking measured risks.
  • A deeply credible scientific reputation. Possesses a solid scientific understanding of products. Understands the importance of strong intellectual property. Able to apply scientific and market knowledge to assess a product’s strategic fit and commercial opportunity. Uses experts effectively.
  • Global orientation with strong collaboration skills. A world class team player. Works effectively in a team-based organization, collaborates cross-functionally, exercises influence at senior levels, and builds alignment around goals and objectives. Readily builds consensus and achieves agreement on key initiatives and priorities. Is energized by and effective in working across cultures and time zones.
  • Communicator who cultivates followership. Able to inspire team, with strong personal charisma and presence. Ability to simplify and convey complex concepts and strategies, orally and in writing. Effectively conducts/facilitates meetings. Strong presentation skills. Excellent listener; seeks broad input and feedback; frequent and effective follow-up.
  • A reputation for unassailable integrity. Possesses unquestioned integrity and strong business ethics. Demonstrates a firm commitment to the company's culture and values. Has the industry reputation and record of achievement to establish trust and credibility with peers, subordinates, collaboration partners, and external constituents.

We offer a competitive benefits package, including:

  • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
  • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
  • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
  • Life and Disability Protection: Company paid Life and Disability insurance.
  • Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
Reports To

Executive Vice President, Global R&D & CMO

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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09.11.2025
T

Teva Sr Manager Statistical Programming United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. Retirement Savings: 401(k) with employer match, up to 6% and...
Description:

The Senior Manager, Statistical Programming, provides comprehensive programming leadership for programming deliverables within a product/program. This role is responsible for managing the timely and accurate execution of programming components of clinical trials and supports the development, regulatory approval and market acceptance of Teva Products.
The Senior Manager leads and manages projects that involve global tasks, cross functional teams, or outsourcing resources. The role requires providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, the Senior Manager of statistical programming supports improvement initiatives, support change management through communication, training, and stakeholder engagement, and proactively address risks with remediation strategies.

How you’ll spend your day

-Primarily works at the product / program level
-Possible to have direct reports; Likely to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources. Mentor Jr Level programmers on the use of department standardization tools/processes.
-Manages and Delivers assignments with quality and within timelines and provides input for budget planning
-Independently develops, validates, and maintains complex programs and utilities in accordance with predefined specifications and standards.
-Provides strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros. Develop, debug, and enhance SAS (or any other Statistical software) programs to support quality control of safety or efficacy derived datasets.
-Reviews key planning documents (e.g, Protocol, statistical analysis plan) to ensure alignment with project objectives, contributes to development of data presentation plan (DPP) , programming specifications (eg. SDTM, ADaM specs) , regulatory reviewers guide documents, ensures clarity and completeness of programming requirements, and robustness of assumptions.
-Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource issues.
-Responsible for the standardization of GSD deliverables across study projects within an indication/therapeutic area.
-Contributes to the overall definition of programming rules and standardization across therapeutic areas and/or indication, including supporting visualization capabilities.
-Identifies, supports process and technology improvement initiatives, communicates proactively and effectively around issues and risks and contributes to remediation strategies.
-Leads global projects with cross-functional involvement; demonstrates project management and leadership capabilities.
-Contributes to departmental policies, standards, and best practices.


Your experience and qualifications

Education Required: Bachelor’s Degree OR Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
Experience Required: Bachelors + 7 year, Masters + 6 years in a pharmaceutical or clinical research setting as a programmer.
Experience Preferred:
Specialized or Technical Knowledge Licenses, Certifications needed:
Functional Knowledge: Expert level of programming skills and problem resolution in SAS or other Statistical programming software. Provide programming and documentation support for SAS (or other Statistical software) system development
Company/Industry Related Knowledge: Advanced knowledge of government regulations pertaining to drug development in multiple therapeutic areas. Strong understanding of clinical data structures (e.g. CDISC). Represent Clinical Programming in healthcare authority inspections.

We offer a competitive benefits package, including:

  • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
  • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
  • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
  • Life and Disability Protection: Company paid Life and Disability insurance.
  • Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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24.08.2025
T

Teva Senior Manager Office Business Integrity United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
Provide professional investigative forensic accounting service and support to the Office of Business Integrity (OBI) by directing, planning, and carrying out sensitive and complex investigations regarding reports of financial misconduct...
Description:
How you’ll spend your day
  • Provide professional investigative forensic accounting service and support to the Office of Business Integrity (OBI) by directing, planning, and carrying out sensitive and complex investigations regarding reports of financial misconduct or fraud, as assigned, ensuring all allegations are confidentially and properly addressed.
  • Evaluate and apply in-depth forensic accounting knowledge in proportion to the allegation and its implications; Determine the investigative efforts required based on the scope and depth of fact-finding needed. Work cross functionally at the business level in sometimes complex or unclear environments.
  • Interact with all levels within the organization and conduct investigations with utmost discretion, objectivity and sensitivity.
  • Serve as subject matter expert on forensic accounting investigative techniques. Maintain expert knowledge FCPA regulations and other specific requirements imposed by government agencies.
  • Create high quality written investigative reports in support of the overall complaint handling process.
  • Report risks and deficiencies, identify trends and partner with management to identify improvements to protect Teva and its assets (people, property, product and proprietary information).
  • Assist with OBI program management responsibilities, as needed, including but not limited to, coordinating consistent responses to reported cases of misconduct, general case management within the hotline reporting system and providing reporting, statistics and trending for key stakeholders.
  • Contribute to Global Compliance & Ethics’ mission by promoting Teva Values, the Code of Conduct and promoting the OBI as an independent, confidential and trusted resource for employees to report concerns.
  • Provide awareness training and support OBI initiatives across the globe, as needed.
  • Follow Teva Safety, Health, and Environmental policies and procedures.
  • Other projects and duties as required/assigned.
Your experience and qualifications
  • Bachelor’s Degree in Accounting or Finance is required
  • Masters or Other Advanced or Professional Degree (preferably in Accounting or Finance-related) strongly preferred
  • A minimum of 8 years overall experience required including: 5+ years of general accounting and audit experience
  • A minimum of 5 years of forensic accounting experience required; in a global pharmaceutical or healthcare company preferred
  • Direct experience independently conducting international bribery and corruption investigations, including leading sensitive forensic interviews, drafting concise investigation reports and communicating with key stakeholders.
  • A minimum of 5 years in the pharmaceutical or health care industry environment with compliance and investigations related experience is required
  • Experience with a “Big Four” accounting firm
  • Bilingual / Multi-lingual preferred
  • Knowledge of the applicable regulations related to government authorities as well as state, local and federal laws governing compliance investigations (FCPA) is required
  • Professional license required in an accounting or compliance related field (CPA, CFE, CIA, CCEP, etc.) preferred
  • Continual advancement / operational knowledge of forensic accounting and investigative techniques in order to continually align with developing risks. Advanced knowledge of typical fraud schemes.
  • Superior writing skills are required. Must be able to communicate effectively both verbally and in writing. Prepare documents that are clearly and concisely written. The responsibilities and complexity of this position require strong and effective communication skills. The individual must possess the ability to professionally interact with all levels of Teva’s corporate infrastructure, as well as that of our business partners, vendors, and all levels of government authorities and law enforcement.
  • Possesses a depth of expertise in investigations management and administration areas. Effectively identifies and understands changes in the risk environment, is able to suggest modifications to investigative methodologies, practices and procedures as appropriate.
  • Demonstrates an ability to set and articulate strategy, drive critical decision making, influence others, and obtain accurate and positive results. Ability to facilitate cross-functional groups to coordinate efforts and elicit efficient responses.
  • Able to coordinate multiple projects simultaneously under tight deadlines. Prioritizes and organizes work effectively to ensure timely and accurate completion of projects.
  • Able to master a complex and global work environment. Develops resolutions to project-related problems of moderate to high level scope. Uses resources available to determine appropriate actions for problems presented.
  • Develops solid working relationships with peers and management. Participates in inter-departmental projects, knowledge management and training. Offers professional support and guidance to other team members. Provides and accepts constructive feedback.

We offer a competitive benefits package, including:

  • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
  • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
  • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
  • Life and Disability Protection: Company paid Life and Disability insurance.
  • Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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27.07.2025
T

Teva Senior Compliance Associate United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
Support drug substance manufacturing process development activities by executing downstream purification steps at bench-scale and pilot-scale. Support the development of new purification technologies to improve the efficiency of the Biologics...
Description:
How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

  • Support drug substance manufacturing process development activities by executing downstream purification steps at bench-scale and pilot-scale
  • Support the development of new purification technologies to improve the efficiency of the Biologics manufacturing process and reduce the cost of goods
  • Execute development studies (for example, virus clearance study) at 3rd party labs
  • Lead a compliant laboratory operation in accordance with SOPs, internal procedures and policies
  • Assist in troubleshooting process and equipment issues and deviations
  • Record experiment results in lab notebooks in compliance with Good Documentation Practice, and perform data analysis as needed
  • Analyze data and present it at internal team meetings and effectively communicate with supervisor(s)/project leads
  • Prepare/review technical documents including development reports, batch records, work instructions, etc
  • Interact cross-functionally with upstream process development, analytical, facilities, and other internal and external functions to support successful process development and manufacturing in pilot-scale lab

Additional Responsibilities / Secondary Duties:

  • Support cGMP (Current Good Manufacturing Practices) clinical manufacturing campaigns in Biologics Manufacturing Facility, when needed
Your experience and qualifications

Qualifications / Education Requirements:

  • BS in Chemical engineering or Biotechnology or Chemistry or Biology or related field
  • Excellent verbal and written communication skills required.
  • Highly motivated individual with the ability to work collaboratively in a team environment.
  • Knowledge of protein chemistry and separation science is preferred
  • Some previous laboratory coursework or experience is preferred.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.


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26.07.2025
T

Teva Associate Director Alliance Vendor Relationship Manager United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
Develop and implement vendor management strategies and tactics, including leadership of and direct support of governance and performance related documents, charters, and tracking/reporting mechanisms for clinical trial vendors as assigned....
Description:

The Associate Director, Alliance/Vendor Relationship Manager will be responsible for managing and optimizing relationships with external vendors supporting Global Clinical Operations efforts of the organization. This role is essential in ensuring that clinical vendors deliver high-quality services on time and within budget while adhering to regulatory requirements and organizational standards.

Strategic Vendor Management:


• Develop and implement vendor management strategies and tactics, including leadership of and direct support of governance and performance related documents, charters, and tracking/reporting mechanisms for clinical trial vendors as assigned.
• Establish and monitor Key Performance Indicators (KPIs), Operational Key Metrics (OKMs), and Key Risk Indicators to ensure vendor performance aligns with project and corporate objectives.
• Cultivate strong, collaborative relationships with vendors to ensure service quality, efficiency, and alignment with the organization’s goals.

Performance Oversight and Governance:


• Oversee the performance of key vendors in partnership with functional stakeholders, ensuring they provide high-quality, timely, and cost-effective services for clinical trials.
• Lead regular governance forums, such as Joint Operating Committees to review vendor performance, address issues, and drive continuous improvement.
• Act as the internal primary escalation point for vendor performance issues, collaborating with providers and stakeholders to develop and execute risk mitigation strategies.

Financial and Contract Management:


• In partnership with internal stakeholders and functions, monitor vendor budgets, forecast expenditures, and report on spending to identify opportunities for cost savings and efficiency improvements.

Compliance and Quality Assurance:


• Ensure that all vendors comply with regulatory requirements (e.g., ICH GCP), industry standards, and company policies.
• Coordinate with Quality Assurance to conduct regular audits and assessments of vendor processes, addressing compliance issues as needed.
• Lead periodic reviews and benchmarking exercises to ensure that vendor performance meets or exceeds industry standards for cost, speed, and quality.

Continuous Improvement and Innovation:


• Drive initiatives to improve vendor management processes, including the adoption of new technologies and best practices.
• Foster a culture of continuous improvement by encouraging cross-functional collaboration and sharing of best practices to enhance overall clinical trial operations.

The person hired for this role will need to work in a hybrid environment out of our West Chester, PA office

Your experience and qualifications


• Bachelor’s degree in Life Sciences, Business, or a related field. An advanced degree (e.g., MBA, MS in Clinical Research) is preferred.


• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in vendor management or a related role in clinical research.
• Demonstrated experience in managing complex Alliance/Vendor Relationships and leading governance activities within a matrix environment.
• Strong knowledge of clinical research and development processes, including regulatory requirements (ICH GCP) and clinical trial operations.


• Excellent communication and interpersonal skills, with the ability to build and maintain relationships with internal and external stakeholders.
• Strong analytical and problem-solving skills, with a focus on optimizing vendor performance and ensuring cost-efficiency.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.

Compensation Data

The annual starting salary for this position is between $139,120– 182,595 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

We offer a competitive benefits package, including:


•Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
•Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
•Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holiday.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.


Reports To

Senior Director, Alliance Management

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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29.06.2025
T

Teva Director Regulatory Affairs - Dossier Project Manager United States, Pennsylvania, East Bradford Township

Limitless High-tech career opportunities - Expoint
Responsible to manage Product Submission Team and dossier timelines. Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management. Regularly reports to management on progress...
Description:

The Regulatory Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers. The Director that fills this highly visible role will work in a matrixed cross functional project team, interacting with contributors and leadership within the R&D environment to align optimal submission plans with demanding timelines in full compliance with external and internal requirements.This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, and the ability to rapidly learn associated Teva systems and planning software. The position requires regulatory knowledge of content requirements of and experience with major applications, including global NCE marketing applications, product line extensions and supplements.
This is primarily an individual contributor role, though it may include managing 1 or more direct reports.

How you’ll spend your day

• Responsible to manage Product Submission Team and dossier timelines.
• Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management.
• Regularly reports to management on progress against objectives and plans.
• Guides project teams on Teva submission-related processes and content and format requirements for key markets.
• In close collaboration with cross functional team members, creates and maintains regulatory project plans that capture detailed dossier content, key activities and timelines required to deliver that content to achieve aggressive submission timelines for highly prioritized major applications.
• Leads submission planning discussions, keeping all stakeholders informed and engaged of upcoming deliverables, aligned on roles and responsibilities, and aware of the interdependencies between R&D activities and submission components. Identify, communicate, and mitigate any issues, risks, or adaptations needed as challenges arise.
• In collaboration with regulatory lead and project leader, conduct scenario planning when multiple regulatory strategies are being considered.
• Communicate key milestones, critical path activities, and ensure transparency of regulatory plan status to stakeholders.
• Understands and advises others on global Regulatory Authority regulations and guidance associated with required submission components, which differ across regions and Regulatory Authorities.
• Provides training and mentorship to regulatory staff.


Your experience and qualifications

• Education Required: Bachelor’s Degree in scientific field or equivalent combination of education and related work experience
• Education Preferred: Ph.D or Masters in relevant discipline, or professional degree (eg, Project Management Professional (PMP), DVM, DDS, MD, PharmD).
• Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years in a related position in regulatory affairs project management with proven regulatory project management experience (creating, filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA).
• Working knowledge of relevant drug and biologic regulations and guidances / guidelines applicable to marketing applications drugs or biologics
• Excellent communication, organizational, and interpersonal skills
• Company/Industry Related Knowledge: must be adept at working and positively influencing upward and laterally in a matrixed cross functional project team and global regulatory team environment
• Proficiency in electronic Document Management Systems (eDMS), Veeva preferred
• Strong understanding of Microsoft Office Suite (Word, Excel, PowerPoint, MS Project)

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Show more
Limitless High-tech career opportunities - Expoint
אחסנת משטחים במערך האוטומטי (עבודה על מלגזה). מיון, רישום וקבלת סחורה במחשב על פי נהלים. ליקוט וביקורת הזמנות ללקוח. פריקת משאיות ומכולות. עבודה מול מחשב (Word, Excel, Outlook). סביבת העבודה...
Description:
How you’ll spend your day
  • אחסנת משטחים במערך האוטומטי (עבודה על מלגזה)
  • מיון, רישום וקבלת סחורה במחשב על פי נהלים
  • ליקוט וביקורת הזמנות ללקוח
  • פריקת משאיות ומכולות
  • עבודה מול מחשב (Word, Excel, Outlook)
  • סביבת העבודה בחלקה הינה חדר קור (טמפרטורה של 5 מעלות בממוצע) וחלקה משרדית מול מחשב
  • העבודה במשמרות ( בוקר/ערב)
Your experience and qualifications
  • חריצות, אחריות, אכפתיות, סדר וארגון ויכולת עבודה בצוות
  • נכונות לעבודה במשמרות –חובה (תתכן עבודת לילה לפי צורך)
  • נכונות לעבודה בשישי / מוצ"ש במידת הצורך
  • נכונות לעבודה בש.נ במידת הנדרש
  • נכונות לעבודה במאמץ פיזי ממושך - חובה (זאת בכפוף לתקנות הבטיחות בעבודה ובהתאם לנהלי הבטיחות שיוגדרו באתר). לשם כך על העובד להיות בעל כשירות פיזית וללא מגבלות רפואיות רלוונטיות.
  • ניסיון קודם בתחום הלוגיסטיקה / מחסן ממוחשב (עבודה בסביבה ממוחשבת ומסופונים) – יתרון! (יתרון לחברות לוגיסטיקה / תרופות)
  • אנגלית ברמה בסיסית – חובה
  • רישיון נהיגה - חובה
  • רישיון מלגזה – יתרון
  • בגרות מלאה – יתרון
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