דרושים Operator Iii - Tapi ב-טבע ב-הודו

The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will assure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly. In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory staff will be the primary responsibilities of the Associate III.

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency
• Independently work on supplements, compile and publish for managements review. Take a proactive approach for more complex submissions and contact internal stakeholders (when needed) to gain further insight on any given supplement. Convey findings to management and incorporate any.all applicable information in the submission to ensure a quality and a right first time submission.
• Assist management and proactively train Associate I’s and Associate II’s on guidance’s, internal processes, procedures, databases and trackers
• Other projects and duties as required/assigned.
• Process improvement

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum 5+ years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience 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.
• 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.

• Technical/functional knowledge in Accounting and fixed asset closing area
• Ensure that capitalization, maintenance, depreciation, amortization are properly recorded and analyzed
• Very well verse with lease accounting concept
• Preparation of Journal Entries, Supporting schedule & Roll forwards
• Perform monthly and quarterly FA closing activities of multiple entities
• Analysis of the various fixed asset accounts and variances per legal entities, obtain explanation on deviations and prepare a summarized reporting on a monthly basis within scheduled time
• Preparation & clearance of open reconciling item in account reconciliations
• Hands on experience in submission of trial balance in HFM
• Identify & drive standardization opportunities in processes and tasks across the team
• Acting as a key contact for local teams for fixed assets and lease related questions
• Ensuring that accounting books and records comply with accounting policies and regulations
• Provide supporting documents and explanations for all internal and external audit as and when required
• Participate in ad-hoc activities and projects

• University education in Accounting or Finance required
• Minimum experience of 3+ years into managing fixed assets & leases register for large scale organization
• Preferably familiar with US GAAP
• Working knowledge of internal controls
• Good working knowledge of SAP
• Good understanding of accounting processes and can follow accounting policies
• Good analytical skills and have hands on experience in Fixed asset as well as Leases process
• Fluent verbal and written communication in English
• Experience in a multinational firm or within a GBS (Global Business Services) is preferred
• Hands-on and proactive; strong organizational skills
• Accustomed to working with deadlines, in a dynamic environment
• Results driven and service oriented to internal and external customers
• Excellent collaboration with colleagues within the local organization and with the colleagues of the global business service to support the overall Finance department’s goals and objectives
• Flexible and able to work in a changing environment
• Strong focus on improvement opportunities
• Want to work in a new (to be) established team
• Process documentations and certifications – will have to ensure that all process are appropriately documented and periodically certified by team members on regular basis

Group Leader Financial Operations

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.

• Bachelors in Computer Science or related degree
• 5 to 10 years Relevant ServiceNow developer experience
• Business Communication and strong knowledge on SDLC process
• Good control on ServiceNow core development concepts:
• Strong ServiceNow base structure knowledge (table dictionary. etc.)
• Update sets
• Client side and Server-Side scripts and associated concepts. Strong knowledge on scripting.
• Good control in integration concepts
• Having good knowledge on Automation activities.
• Strong knowledge on service catalogs workflows flow designer and automating flows.
• Service Portal Knowledge (Agent workspace is optional but preferable)
• Implementation knowledge on ITSM and NON ITSM modules. (Non ITSM modules includes HRSM, CSM, GRC, Facility…etc.).

• Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.

1. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.
2. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
3. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV triggered and non-PV triggered safety updates (e. g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
4. Scientific Work & Authority Communication
• Respond to authority deficiency letters in collaboration with other departments.
5. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.

• Experience: 5 to 6 years in relevant fields, (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry)
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European Pharmaceutical Law and Regulatory Affairs.

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.

• Partner with Sales and Marketing Incentive Compensation teams to support IC related activites.
• Analytical support of the design, implementation, evaluation, and reporting of incentive compensation reports, and results including development and deployment; identifies and leverages opportunities to enhance planning and reporting processes
• Collaborate with key stakeholders to streamline workflows, ensure proper data integration, and establish best practices for managing incentive compensation processes in-house
• Develop processes to improve the efficiency, accuracy, and scalability of incentive compensation functions
• Provide data research, investigation, and analysis to resolve issues and inform operational decisions.
• Support and implement Sales Planners’ initiatives across multiple Brands and Sales Forces.
• Maintain and monitor CDW data and processes. Report on data quality and process performance.
• Work with Internal and external partners to maintain the CDW technical platform’s integrity and performance.
• Meet all defined requirements of the Requests or Projects
• Manage Service Requests and Projects from design to implementation.
• Automate data, application processes to drive process improvement.
• Provide regular project updates to business analysts and management as needed.
• Communicate issues, risks, and concerns proactively to management.

Education and Knowledge Requirements
• Bachelor’s degree in Computer Science or 4+ years relevant experience.
• Minimum 3 years of experience as a Developer
• Minimum 3 years of experience working in a Commercial Pharmaceutical environment.
• Minimum 3 years of experience developing SQL. Vertica databse experience preferred.
• Minimum 2 years of experience in working with global cross-functional teams preferred
• Demonstrated experience in project estimation and planning.
• Pharmaceuticals industry experience and knowledge a plus.

Skills and Capabilities
• Excellent written and verbal communication skills.
• Strong Excel and SQL database skills are required, Vertica database experience preferred
• Ability to work independently and as part of a team while demonstrating initiative and using good business judgment.
• Ability to be flexible set priorities, and meet deadlines in a rapidly changing environment for self and team.
• Effective decision-making and critical thinking skills for problem identification and solution recommendation
• Experience working in AWS or Azure Cloud environments
• Data Analysis, Engineering, Data integration expertise
• Organization and Time management skills
• Proficiency with MS Office tools and applications
• Familiaritty or experience with SalesForce.com or Veeva CRM (Optional)
• Experience or familiarity with development and integration technologies such as TOAD, SQL Developer, DB Visualizer, Power Center, Snap Logic, etc. Preferred

As a Project Manager (7-8 years experience), you will be responsible for managing large-scale, multi-million-dollar transformation projects, primarily focusing on Cloud Migration and Data Center Consolidation. You will collaborate closely with cross-functional teams, senior leadership, clients, and vendors to ensure successful project delivery while driving alignment on project goals, timelines, and budgets. Your leadership and strategic insights will help drive the transformation efforts to meet business objectives and exceed client expectations.

1. End-to-End Project Management:
o Develop and manage comprehensive project plans, timelines, and budgets to deliver the project on time and within budget.

2. Stakeholder & Vendor Management:
o Serve as the primary point of contact for internal stakeholders, clients, and vendors, ensuring seamless communication and transparency across all parties.
o Manage relationships with key stakeholders, providing regular project updates and ensuring the alignment of expectations.
o Coordinate with third-party vendors and contractors for resource allocation, service delivery, and technical support.

3. Risk & Issue Management:
o Proactively identify and mitigate risks associated with Cloud Migration and Data Center Consolidation projects.
o Establish clear processes for issue tracking, escalation, and resolution to ensure minimal disruption to project timelines.
o Implement risk management strategies to protect project timelines, budgets, and quality standards.

5. Financial & Budget Management:
o Own project financials, ensuring accurate forecasting, cost control, and delivery within the approved budget.
o Track project expenditures and identify potential cost-saving opportunities without compromising quality.

6. Process Improvement & Best Practices:
o Continuously evaluate and improve project management processes and methodologies.
o Ensure that projects are executed in line with industry best practices and internal standards, including Agile and Waterfall methodologies, depending on project needs.

7. Cloud & Data Center Transformation Expertise:
o Leverage deep expertise in Cloud Technologies (AWS, Azure, Google Cloud) and Data Center Infrastructure to drive successful project outcomes.
o Provide strategic guidance on cloud architecture, migration strategies, and data center optimization efforts.
o Stay current on emerging trends and technologies in the cloud and infrastructure space to provide valuable insights to the team and stakeholders.

• 7-8 years of experience in managing large-scale infrastructure projects, with a focus on Cloud Migration and Data Center Consolidation.
• Bachelor’s degree in Engineering, Computer Science, Business Administration, or a related field.

As a Project Manager (7–8 years of experience), you will work on high-impact AMS transformation programs. You will coordinate across a diverse set of applications and stakeholders, helping ensure service continuity, regulatory compliance, and continuous improvement while supporting cross-functional delivery teams, senior leadership, and vendor partners.

1. AMS Project Delivery & Governance
• Ensure smooth and compliant execution of AMS operations, meeting SLAs, KPIs, and GxP standards.
• Support managed services initiatives for enterprise applications like MES, Veeva, SFDC, CRM, ReadSoft, and PLM.
• Drive transformation across people, process, and technology under a service-oriented model.
2. Stakeholder & Vendor Management
• Collaborate with internal IT teams, business stakeholders, and global vendor partners to align on project objectives.
• Coordinate with multiple vendors for service delivery, pricing discussions, and performance tracking.
• Support contract management activities including SoWs, change requests, and procurement coordination.
3. Planning, Tracking & Risk Management
• Contribute to planning and tracking of budgets, schedules, and deliverables for multi-million-dollar AMS programs.
• Identify, assess, and mitigate risks and issues impacting project timelines and service outcomes.
• Maintain structured documentation and reports aligned with internal audit and regulatory requirements.
4. Communication & Reporting
• Prepare and deliver executive-level project updates, dashboards, and service review reports.
• Facilitate cross-functional communication across business, IT, and vendor ecosystems.
5. Process Discipline & Compliance
• Ensure full adherence to GxP and pharmaceutical regulatory standards.
• Promote documentation and audit-readiness culture across AMS lifecycle.

• 7–8 years in project management, with at least 5 years in AMS or transformation in large-scale environments.
• Familiarity with pharma regulations (GxP), AMS operating models, and regulated application landscapes.