

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.
משרות נוספות שיכולות לעניין אותך

We offer a competitive benefits package, including:
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.

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.
-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.
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:
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.

We offer a competitive benefits package, including:
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.

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.
Additional Responsibilities / Secondary Duties:
Qualifications / Education Requirements:
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.

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
• 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.
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.
Senior Director, Alliance Management
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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.
• 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.
• 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.

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.
משרות נוספות שיכולות לעניין אותך