The Role:To ensure that Investigator Brochures are created, revised and submitted in compliance with governing SOPs and ICH requirements. The IB Manager compiles the Investigator...
To ensure that Investigator Brochures are created, revised and submitted in compliance with governing SOPs and ICH requirements. The IB Manager compiles the Investigator Brochure and is responsible for proactive end-to-end project management of the Investigator Brochures within agreed timelines and in accordance with ICH guidelines.
- Chair IB kick off meetings, leading IB discussion whilst utilizing IB expertise to support the team in updating an IB within the required timeframe.
- Acts as an end to end project manager for IBs. Responsible for IB compilation of distinct sections into a cohesive document fit for submission purpose. Prepares deliverables in accordance with SOPs, regulatory guidance and internal job aides.
- Closely monitors project timelines associated with specified documents and tables and ensures delivery of necessary contributions according to timelines.
- Ensures compliance of IB updates with ICH requirements. Interprets current and new ICH and external regulatory requirements. Proposes function implementation of new emerging ICH guidance/regulations and provides impact assessments.
- Provides content consultation to product teams and other IB managers on ICH and CIOMS regulatory IB requirements
- Ensures that IBs are notified to Alliance Partners, as appropriate, so that distribution to end customers occurs in line with business expectations. Monitors internal process and CTPQS alignment of AP IB distribution. Challenges metrics and delivery dates of IBs to sites.
- Ensures that corporate systems used to store and track IBs are maintained in real time. Leads system and process change. Highlights potential gaps, proposes solutions and leads implementation.
- Confident in producing metric dashboards and root cause analysis. Proactively evaluates current systems and processes and actively offers suggestions for systems and process improvements.
- Acts as a mentor to new starters and managers in the team, providing training in day to day activities and IB technical knowledge
- Functions as a change agent that can exhibit IB knowledge and awareness, technical competence, sound judgment, and a professional demeanour
- Must be able to act as an SME & POC for all inspections and audits.
- B.S./B.Sc is in Pharmacy, Life Sciences
- Relevant experience of working in an IB role.
- Excellent organizational, project management and communication skills
- Understands external IB regulations and is confident in application and interpretation of the guidance
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.