דרושים Global Corp Affairs Stakeholder Senior Manager ב-טבע ב-Croatia, Zagreb

Croatia, Romania or Poland

• Support the development, maintenance, and implementation of medical communication strategy, plans, and tactics in the assigned therapeutic area(s) and manage relationships with both internal and external stakeholders
• Understand and interpret clinical trial data, the literature and associated therapeutic conditions
• Coordinate cross-functional publication strategy and core teams in the development of medical publications and scientific congress strategy and plans
• Ensure execution of publication plans is consistent with department objectives and TA strategy
• Ensure oversight of publication records in Teva’s publication tracking tool
• Understand industry and publication guidelines, ICMJE and GPP in particular
• Provide input into key medical/scientific communications concepts and terminology development
• Be accountable for the timely delivery of high quality, message-focused medical communications to target audiences
• Establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress secretariats to drive high quality medical communications activities
• Develop and maintain general or special issues publication advisory boards for assigned therapeutic areas, including recruitment of advisors, meeting planning and execution, content development, and documentation of action items
• Forecast financial resources with business case preparation and oversight as required and to deliver the publication plans within budget
• Integrate medical communications agencies/contract freelancers as part of the extended team for medical communications activities
• Acquire and maintain thorough understanding of industry and publications standards with respect to quality, authorship and appropriateness of medical/scientific communications
• Ensure that medical/scientific communications activities are within compliance

• Bachelor of Science or Communications degree required; advanced scientific degree preferred (MD, PhD, PharmD)
• Minimum 3 to 5 years of experience in Industry with relevant medical/scientific focus
• Knowledge of Good Publication Practices and ICMJE Guidelines
• Knowledge of Global Medical Affairs in the Pharmaceutical/Biotech Industry
• Proven track record of establishing strong partnerships with senior stakeholders as well as delivering medical communications plans and tactics
• Project management skills and financial acumen
• Experience with management of publication projects via publication tracking database (i.e. Datavision, PubStrat)
• Excellent interpersonal and communications skills
• Strong client engagement and relationship management skills
• Ability to influence and work with cross-functional teams to deliver complex projects
• Experience with Medical Affairs and Medical/Scientific Communication practices and processes

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.

• Requirement Analysis: Analyze business requirements and perform thorough Impact analysis
• Solutioning & Design: Solutioning for new SAC (SAP Analytics Cloud) planning application implementations and also for enhancements to existing planning applications.
• Prepare High level and detailed design specifications related to SAC Planning model and Import/Export interfaces from/to SAP BW/Datasphere/Oracle databas
• Collaboration: Collaborate with Technical, Stakeholder management and Cross functional teams
• Delivery : Contribute and lead the delivery of SAC Planning application Implementation, enhancements and Interface developments
• Project Status updates : Timely updates of the ongoing development tasks and incident resolution status to the management and concerned teams
• Technical Ownership : Assume technical ownership ensuring tight control over all the technical aspects of the application and adhering to established governance and best practices
• Project Support: Monitor Service Now incidents, JIRA tasks and track them to closure
• Technical Documentation: Prepare and maintain the technical documentation and user guides

• : Bachelor's or Master's degree in Finance, Accounting, Business Administration, or Information Technology.
• 12 + years of experience in the areas of Planning and Analytics
• Minimum 3-4 end to end Planning/Budgeting/Forecasting implementation experience using SAC (SAP Analytics Cloud) Planning
• Strong Understanding and experience of implementing Financial Planning and Standard Financial statements : P&L, Balance Sheet and Cash Flow is a must
• Experience in developing Advanced formula, Data actions
• Extensive experience in Stories and dashboards with rich visualization.
• Experience with setting up User Security in SAC
• Experience with Inbound and Outbound data integrations/interfaces with upstream and downstream systems is a must
• Experience with scripting for Analytical applications is an added advantage
• Strong excel skills
• Data reconciliation and troubleshooting skills
• Hands-on experience with SAP BW / SAP Datasphere
• Hands-on experience in developing simple to Medium complexity SAP HANA Calculation views
• Good Understanding / Hands-on experience in SQL is an added advantage
• Past experience in other Planning tools like BPC standard, BPC Embedded , BW-IP, Hyperion Planning etc. is an added advantage
• Client interfacing skills and experience in interfacing with Senior management and Business users/end users
• Self motivated and quick learner and has the ability to adapt to highly dynamic environment

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.

• Design and execution of Extractable and Leachable (E&L) studies, incorporating LC/UV/MS or GC/FID/MS analytical techniques.
• Development and validation of analytical methods incorporating Mass Spectrometry detection (LC/MS or GC/MS).
• Support the characterisation of polymer materials used in medical devices and packaging, including inhalation and injectable drug products, for both small molecules and biopharmaceuticals.
• Assist in the interpretation of Mass Spectrometry (MS) data as part of compound identification studies.
• Instigate and drive scientific and technical investigations developing multidisciplinary approaches to solve wide ranging and complex problems.
• Compilation and review of detailed technical documents.
• Deliver high levels of customer service (both internal & external)

• Temporary (maternity leave cover)

• Degree, Masters or PhD qualification in Chemistry (or related discipline), with minimum 3 year’s work experience with analytical method development and validation.
• Experience in analytical method development and validation with mass spectrometry is highly desirable.
• Experience with Empower and MassHunter software is highly desirable.
• Excellent communicator (both oral and written).
• Experience of working to current Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) and implementing policies and procedures in line with regulatory guidelines.
• Knowledge of regulatory and compliance requirements.
• Good planning and organising skills, adaptable to changing priorities.

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 Manager, Complex Gx, Regulatory Affairs is responsible for the supervision, preparation, critical review, and submission of high quality regulatory submissions—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager serves as team leader for projects and is responsible for overseeing the evaluation of change controls. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance’s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The primary responsibilities of the Manager include the preparation and compilation of original applications, amendments, deficiency responses, postapproval supplements, and training of regulatory staff.

• Independently support the preparation, review, and compilation of regulatory submissions (original applications, supplements, and responses) for sterile complex generic products.

• Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Other projects and duties as required/assigned.

• Pharm D/BS in a scientific discipline or equivalent education and related experience

• Master’s degree in RA/QA discipline, preferably in Pharma.

• Minimum 8+ years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience with sterile products required, coupled with 2 years analytical/QC, R&D/laboratory or production experience is preferred.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates excellent verbal and written communication skills.
• Shares concepts, ideas, information, and suggestions with management, peers and others.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.

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.

1. Data Collection and Processing
   Promote and ensure accurate and efficient collection, processing of periodic environmental data collectionprocesses environmental sustainability data.
2. Data Integrity and Standardization Management
   Monitor, validate, Investigate, communicate and support improvements implementations to enhance dataaccuracy, consistency, and reliability.
3. Quantitative Data Reporting and Disclosure
   Consolidate and report (internally and externally) data in alignment with Sustainability team expectationsand Reporting system format;
   Regulatory or ranking platforms expectations.
   Validate per-assured data and escort assurance processes
4. Data Analysis, Interpretation and communication
   Conduct in-depth analyses to answer management queries, identify trends, insights, and opportunities forimprovement. Operate predictive model to support environmental performance forecasting and decision-making (e.g. Decarbonization Model).
   Provide clear and data visualizations to support effective communication, different stakeholders andbusiness needs.
5. Advisory on Data Management Enhancement
   Provide insights and recommendations for data management improvements through lessons learnedsessions and prioritized projects

Data Management & Processing

• Proficiency in Excel (advanced), Power Query, and data wrangling technique
• Experience with ETL processes (Extract, Transform, Load)
• Understanding of data integrity, quality control, and standardization

Data Analytics & Modeling

Competency in data analysis using tools such as:

• Power BI developer (for dashboards and visualizations)
• Python or R (for deeper statistical or trend analysis) – optional but preferred
• Experience operating or maintaining predictive models (e.g., emission forecasting, MACC, cost-benefit analysis)

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.

Your responsibilities will include:

• Providing support in HR related matters to Teva employees based in Latin America.
• Entering and maintaining employees’ data in the SuccessFactors system (following the employee life cycle from hire to retire).
• Working closely with the Payroll department ensuring payroll data accuracy.
• Acting as a liaison between the employee and HR managers in order to resolve queries and issues.
• Acting as a first point of contact via ticketing system responding to a broad range of HR related inquiries.
• Ensuring integrity of HR databases and any downstream impact with any/all changes

• Fluent verbal and written communication in Spanish and in English
• Good knowledge of MS Office tools (Excel, Word)
• Experience of working in similar administrative jobs is desirable
• Customer and team oriented
• Willingness to work in an international environment

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.

• Provide legal counsel research and development activities, data privacy, and data transfer matters.
• Draft, review, and negotiate a wide range of R&D-related agreements, including
  • Consultancy and service agreements
  • Research collaborations and MTAs
  • Investigator-initiated studies
  • Licensing agreements
  • academic collaborations and research consortiums.
• Advise on regulatory compliance, transparency, pharmacovigilance, and inspection readiness.
• Collaborate with internal legal, IP, compliance, and privacy teams to ensure alignment with applicable laws, regulations, and internal policies.
• Contribute to continuous improvement of legal processes and templates.
• Support other legal projects and initiatives as needed.

• Master of Law or equivalent European / International legal degree; bar admission required.
• 3–8 years of relevant legal experience, ideally in a law firm, pharmaceutical company, or academic research setting.
• Solid understanding of legal and regulatory frameworks related to clinical research and drug development.
• Strong contract drafting and negotiation skills.
• Ability to assess complex legal issues and provide clear, actionable advice.
• Excellent communication and interpersonal skills with the ability to work effectively with stakeholders in different time zones;
• Team-oriented with a proactive, solution-focused mindset.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
• High level of integrity, professionalism, and commitment to ethical conduct.

• Strong business acumen
• Techniques to work effectively under pressure, meet deadlines, and adjust to changing priorities.
• Ability to think strategically and tackle complex problems
• Ability to identify, advise on, minimize business risks, and propose practical solutions
• Strong customer-orientation; an ability to see issues from the point of view of others
• Ability to work successfully and cooperatively with colleagues across multiple cultures and time-zones
• Substantive experience in Word, Excel, and PowerPoint

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.