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Clinical Director

Pharmexon is looking for an experienced Clinical Director. The role includes the responsibilities for writing and reviewing, technically and grammatically accurate CTD Modules, Biowaiver, Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs) and Environmental Risk Assessment (ERA). The ideal candidate will have experience of current EU requirements, legislations and guidelines. In addition, the role includes the responsibility for performing systematic literature search and review to use as bibliographic support.

Key Responsibilities

  • Author and/or review regulatory submission documents, eg, CSRs, CTD summary documents (2.7.3, 2.7.4, possibly 2.7.1, and 2.7.2), and Clinical Overviews (2.5), Integrated Summaries of Efficacy and Safety, Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers, and applications for Orphan Drug Designations, Provide direction to team on content and optimal data presentation/summarization in the document - Working across therapeutic areas to provide expert support as needed.
  • Develop the strategy for document preparation and the document review processes, including the management of timelines.
  • Facilitate document review meetings and discussions.
  • May act as medical writing lead on submissions or new programs, including early development programs, Briefing Books, feasibility reports and other development-based research.
  • Manage experts and content for Scientific Advice meetings
  • Oversee a team of medical writers (internal and external)
  • Working closely and coordinate with Pharmexon ex-Agency expert panel for all projects.
  • As necessary, may assume primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
  • Expertise in managing Due-diligence / Audits / Monitoring activities.
  • Collaborate with internal and external resources to achieve high quality, timely program level submission deliverables.

Qualifications nad Skills

  • Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 2-4 years of regulatory writing and submission experience.
  • Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books, literature searches.
  • Excellent grammatical and communication skills, both written and oral.
  • Experience in broad spectrum therapeutic areas preferred.
  • Ability to work with complex projects, within cross-functional teams, and under tight timelines.
  • Requires attention to accuracy, quality, and adherence to format and stylistic requirements.
  • Expertise in MS WORD and reference compilations.

Preferred Qualifications

  • Preferably with additional experience in review and/or creation of RMP, PSURs, PIP, ODD and waiver documents for regulatory submissions
  • Masters or PhD degree in science with at least 2-4 years of regulatory writing and submission experience.

Benefits

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    • Full-time
    • Clinical Director
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    Pharmexon Consulting s.r.o.

    • Štěpánská 65
      110 00 Prague 1
      Czechia
    • File number: C 260981
      Held at the Municipal Court in Prague
    • Company number: 05267846
    • If you have any questions about any of our products or if you wish to report an adverse event, please contact us on: safety@pharmexon.com
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