Lead Scientist, Module 3 Dossier Development
£60000 - £65000 per annum
England
(Hier) Bewerben

Overview:

SciPro are currently supporting a global leader dedicated to transforming addiction from a human crisis to a recognised and treated chronic condition. With a vision to ensure worldwide access to evidence-based treatments for substance use disorders (SUD) and associated co-occurring conditions, this organisation focuses on expanding access to quality care. Leveraging a strong portfolio of opioid use disorder treatments and an innovative pipeline.

Position Summary:
The Scientific Writer will work within the R&D Chemistry, Manufacturing, and Controls (CMC) team, specialising in Module 3 Dossier Development. The role involves drafting, reviewing, and approving regulatory documents to support the development and maintenance of new and existing dossiers from Phase 1 through post-approval.

Essential Functions:

  • Develop and maintain Module 3 dossiers (CTD, IMPD, IND, MAA, NDA, ASMF, and DMF), including Module 2.3 QOS, for drug substance and drug product.
  • Author, review, and approve regulatory submission documents and prepare responses to Health Authority queries.
  • Support CMC-related regulatory changes in response to new intelligence.
  • Manage CMC aspects of change control for existing licenses.
  • Drive project milestones, ensuring timely delivery.
  • Maintain expertise in ICH guidelines, EMA/FDA guidance, and local regulations, applying them across all activities.
  • Contribute to Module 3 strategy meetings, risk assessments, and stakeholder interactions by leveraging regulatory and technical expertise.
  • Collaborate with external partners, global regulatory teams, QA, supply chain, and other stakeholders to deliver Module 3 documentation.
  • Promote continuous improvement of CMC functions by integrating new technologies and processes.

Minimum Qualifications:

  • Education: Bachelor's degree or higher in Chemistry or a relevant scientific discipline.
  • Industry Experience: 5-10+ years of experience in scientific writing and/or reviewing Module 3 dossiers in CTD format.
  • Technical Skills: Proficiency in Microsoft Office applications (Word, Outlook, PowerPoint, Excel).
  • Competencies:
    • Strong problem-solving and technical troubleshooting skills.
    • Ability to think critically and offer novel solutions to challenges.
    • Proven experience working in fast-paced, cross-functional environments.

Preferred Qualifications:

  • A 2:1 or first-class degree.
  • Knowledge of drug substance requirements, such as ASMF/DMF.
  • Familiarity with global regulatory requirements (e.g., US, Europe, Canada).
  • Experience with document management systems like Veeva or D2.
(Hier) Bewerben
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