Medical Writer

2 weeks ago

Dublin, Dublin City, Ireland Tata Consultancy Services Full time

Direct message the job poster from Tata Consultancy Services

Recruiter - Leadership & Strategic Hiring UK&I at Tata Consultancy Services

Role: Medical Writer

Location: Dublin, Cork

Ready to utilise your expertise in medical writing? Make a meaningful impact as a Medical Writer.

The Role:

As a Medical Writer, you will be working on medical writing within the clinical research/pharmaceutical industry, with a strong focus on Phase 1 and Phase 2 clinical trials. This role requires a deep understanding of ICH GCP guidelines, regulatory requirements, and compliance standards set by relevant agencies (e.g., FDA, EMA). In this role you will play a critical role in developing high-quality, scientifically accurate, and regulatory-compliant clinical trial documents that support the development of innovative therapies.

Key Responsibilities:

  1. Document Development and Writing
    • Author, review, and finalize high-quality clinical trial documents, including but not limited to:
    • Study Protocols and Protocol Amendments: Develop comprehensive and scientifically rigorous protocols that align with regulatory and ethical standards.
    • Initial Investigator's Brochures (IB) and IB Updates: Create and update IBs to ensure they reflect the most current clinical and non-clinical data.
    • Clinical Study Reports (CSRs): Prepare detailed and accurate CSRs that summarize study results and support regulatory submissions.
    • Develop and edit manuscripts for publication in peer-reviewed journals, ensuring they meet journal-specific guidelines and uphold the highest standards of scientific integrity.
    • Ensure all documents are written in clear, concise, and grammatically correct English, adhering to regulatory and company-specific guidelines.
  2. Regulatory Compliance and Quality Assurance
    • Ensure all documents comply with ICH GCP, regulatory requirements, and internal SOPs.
    • Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.
    • Review and interpret clinical data to ensure accuracy and consistency in documentation, aligning with study objectives and regulatory expectations.
    • Collaborate with cross-functional teams (e.g., clinical operations, biostatistics, regulatory affairs) to incorporate feedback and ensure alignment with study objectives and regulatory expectations.
    • Maintain audit-ready documentation, including version control, review comments, and approval signatures.
  3. Scientific and Literature Support
    • Conduct thorough literature reviews to support clinical research projects, ensuring that all documents are grounded in the latest scientific evidence and industry best practices.
    • Synthesize complex scientific and clinical data into clear, concise, and compelling narratives for regulatory submissions, publications, and internal communications.
  4. Project Management and Coordination
    • Plan and manage timelines for document development, ensuring timely delivery of high-quality deliverables.
    • Coordinate with internal and external stakeholders (e.g., investigators, regulatory agencies, CROs) to gather necessary inputs and resolve queries.
    • Demonstrate strong time management skills to handle multiple projects simultaneously and meet tight deadlines.
  5. Collaboration and Communication
    • Work effectively across cultures and time zones, fostering collaboration with global teams.
    • Provide expert guidance to team members on medical writing best practices, regulatory requirements, and document standardization.
    • Present complex scientific and clinical data in a clear and concise manner to diverse audiences, including non-scientific stakeholders.
  6. Document Management
    • Ensure final documents and supporting quality check documentation are archived in the appropriate document management system.
    • Maintain organized records of all drafts, revisions, and approvals for future reference and audits.

Key skills/knowledge/experience:

  • Professional experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.
  • Strong understanding of clinical research methodologies and regulatory requirements [In-depth knowledge of ICH GCP guidelines, and compliance standards (e.g., FDA, EMA)]
  • Ability to work independently and as part of a team.
  • Proven track record of authoring and managing regulatory documents such as study protocols, IBs, and CSRs.

TCS is consistently voted a Top Employer in the UK and globally. Our competitive salary packages feature pension, health care, life assurance, laptop, phone, access to extensive training resources and discounts within the larger Tata network.

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