דרושים Mgr Scientific Writing ב-טבע ב-India, Bengaluru

Key Responsibilities:

• Planned Engineering Activity
  • Development and ownership of engineering and maintenance plans for routine and project-based activity.
  • Coordination of shutdown, preventive, and corrective maintenance planning.
• Spares Management
  • Ensure spares and consumables are available ahead of planned work.
  • Minimise downtime through proactive inventory management.
• KPI Management and Reporting
  • Manage and report on key engineering KPIs (e.g. schedule adherence, PM/Breakdown PM ratios, mean time to repair, downtime trends).
  • Provide insights and recommendations to maintenance leadership.
• Engineering Stores Ownership
  • Full ownership of inventory processes: classification, stock levels, critical spares review, obsolescence management.
  • Lead periodic reviews and implement continuous improvement in materials management.
• Stakeholder Engagement & Supplier Management
  • Act as key liaison with MRO & consumables supplier for material planning, performance tracking, and issue resolution. Owner of the relationship with external supplier for MRO materials.
  • Engage cross-functionally with engineering, facilities, utilities, supply chain, and operations leaders.

Do You Have?

• Technical qualification in Mechanical, Electrical, or related Engineering field (HNC/HND or higher preferred).
• Planning or maintenance certification (e.g, SMRP, CMRP, APM) would be desirable.
• Experience in a regulated industry essential.
• Pharmaceutical experience preferred with any understanding of industry standards (GMP, GEP, FDA, MHRA expectations).
• Previous experience of leading/supporting maintenance planning and scheduling initiatives.
• Working knowledge of CMMS, strong preference of SAP (PM).

Are You?

• Data-driven mindset with ability to extract and present actionable insights.
• Strong organisational skills, attention to detail and ability to manage multiple priorities.
• Effective communicator across technical and non-technical stakeholders.

Whether you're growing your family or pursuing new adventures, our enhanced maternity and paternity leave, sabbaticals, and hybrid working policies are here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer an enhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structured training and development programme tailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

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 Scientific Writer is responsible for providing high-quality writing support and project management of scientific communication projects in compliance with good publication practices. This includes abstracts, congress presentations, and manuscript for peer reviewed medical journals. The role requires strong scientific knowledge, excellent writing skills, and the ability to translate complex clinical data into clear, accessible content tailored to healthcare professionals (HCPs), patients, and other stakeholders both external and internal.

Scientific Knowledge

• Possess the ability to understand a therapeutic area and product strategy to ensure scientific communication objectives are met.
• Learns quickly to understand a new therapeutic area and the ability to adapt work across multiple therapeutic areas.
• Translate complex scientific information and clinical trial data into content that meets the needs of various audiences, including HCPs and patients.

Medical Writing and Publication Management

• An ability to write key scientific communication deliverables such as abstracts, posters/presentations, and manuscripts.
• Collaborate with Scientific Communication Leads and Therapeutic Area Leads to ensure global content is relevant, up-to-date, and aligned with evolving data.
• Maintain robust version control and document tracking to ensure transparency, audit-readiness, and traceability in Teva’s publication tracking tool.
• Ability to adapt writing style for varied audiences such as specialist healthcare professionals, patients, nurses, patients, caregivers, and other stakeholders.
• Monitor scientific literature and new publications for impact on existing content and update accordingly.

Collaboration & Review

• Ability to establish relationships with authors, external experts, and clinical trial investigators to ensure efficient development of high-quality publications.
• Work cross-functionally with Medical Affairs, Clinical Development, Safety, and other teams (internally and externally) to gain input and approval of scientific communication deliverables.
• Support localization or adaptation of global content to meet regional or market-specific regulatory and cultural needs.

Quality & Compliance

• Understand and apply knowledge of Good Publication Practices such as ICMJE Guidelines related to the development of scientific communication deliverables.
• Follow internal SOPs, style guides, and established workflows to ensure consistency and compliance.
• Conduct peer reviews of content developed by other writers to uphold high quality standards.

Innovation & Continuous Improvement

• Participate in initiatives to enhance the content development process, including use of AI tools, structured content libraries, and digital asset management systems.
• Support the development of derivative content assets such as field medical affairs materials, congress preparation content, and other digital assets.

• Education: Advanced degree (PharmD, PhD, MD, or Master’s in Life Sciences or related field) required.
• Language: English (Professional level competency)
• Experience:
• 10-12 years of experience in medical writing, medical information, or scientific communications within the pharmaceutical, biotech, or medical device industry.
• Experience with medical publication writing, scientific literature analysis, and congress content preparation.
• Knowledge of Good Publication Practices and ICMJE Guidelines
• Familiarity with publication management systems (e.g., Datavision, Pubstrat, Komodo) and publication workflows.

A Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

• Primarily works at a project level.
• Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator’s brochures, health authority responses, and other submission documents (e.g., module 2.5 and modules 2.7.x).
• Compiles, analyzes, and summarizes data from various sources.
• Conducts proofreading, editing, document formatting, and comment resolution.
• Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• May participate in the preparation/revision of document templates and SOPs.
• May train and support medical writers or external vendors/contractors on document planning, processes, and content development.

• Bachelor's, Master's, MD, PhD, PharmD in life sciences (or other related field).
• Preferred Master's, MD, PhD, PharmD.
• University degree with a minimum of 5+ years of relevant experience; advanced degree preferred.
• Proficient as lead author writing protocols/protocol amendments, clinical study reports, investigator’s brochures, and clinical summary documents (modules 2.5 and 2.7.1-2.7.4)
• 6+ years with an advanced degree.
• Travel Requirements: Up to 10%

• Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
• Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
• Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.

Regulatory Submissions

• Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.
• Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
• Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)

Regulatory Intelligence/Expertise/Guidance/Education

• Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
• Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams..
• Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
• Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
• Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
• Work closely with market RA in APAC region to complete all assigned activities

• B. Pharm / M. Pharm (preferred) with 10+ years of experience
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
• Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)

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.

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.

• 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.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update).
• 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.

CONTD...

1. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
2. 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).
3. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
4. Mockups
• Coordinate creation and approval of packaging mockups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
5. Training
• Assist with training new team members

• Experience: 6 to 7 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), preferably with a PhD.
• Other: Advanced English (spoken and written), strong MS Office skills, knowledge of European pharmaceutical law and regulatory affairs.