Tasks

  • Scientific Writing & Submission Lead: Independently draft, edit, and finalize a broad range of regulatory documents. Your focus will include CTD Module 2 summaries, Clinical Overviews, CSRs, Investigator Brochures (IB), and Pediatric Investigational Plans (PIPs)
  • Regulatory Strategy: Provide expert scientific and strategic guidance to study teams. You will offer insights on data pooling strategies and ensure that all content aligns with global filing requirements
  • Data Analysis & Review: Collaborate on the planning of data presentations. This includes a critical review of Statistical Analysis Plans (SAPs) and ensuring the scientific integrity of data displayed in CSRs
  • Health Authority Interactions: Lead the preparation of Briefing Books, 120-day Safety Updates, and formal responses to questions from global Health Authorities
  • Cross-functional Leadership: Act as a central point of contact for stakeholders in Clinical Sciences, Biometry, Drug Safety, CMC, and Regulatory Affairs to ensure document consistency
  • Vendor & Project Management: Oversee external medical writing service providers (Vendors) to ensure quality and on-time delivery
  • Mentorship: Serve as a subject matter expert and mentor for junior writers, fostering a culture of excellence and internal knowledge sharing

Qualifications

  • Academic Background: You hold a Bachelor’s degree in Life Sciences (mandatory), though a Master’s degree or PhD is strongly preferred
  • Professional Experience: You bring at least 5 years of dedicated experience in regulatory/medical writing within the pharmaceutical industry
  • Therapeutic Expertise: Proven experience across various indications is required, with a strong preference for candidates with a background in Cardiology
  • Technical Knowledge: Deep understanding of global regulatory guidelines (e.g., ICH-GCP) and the eCTD structure
  • Communication & Drive: You possess advanced interpersonal skills, allowing you to manage complex stakeholder groups and meet tight deadlines under pressure
  • Language Skills: Full professional proficiency in English (written and verbal) is essential