Location: London, UK
Reporting to: Director of Advanced Analytics
Job Summary
The CMC Technical Documentation Specialist will be a member of the Global Technical Development team and will be responsible for preparing and drafting CMC source documents for use in global regulatory filings such as Investigational New Drug (IND) Applications, Investigative Medicinal Product Dossiers (IMPD), and CMC sections of Health Authority Meeting Briefing Books. This position will require close cross-functional collaboration with the CMC functions and the Regulatory CMC team and will have full accountability to drive continuous improvement in the process of source document creation with the goal of streamlining the translation of these technical documents into regulation filings. This is an exciting opportunity for a well-qualified candidate to join a global company with a diverse and dynamic work environment focused on transforming the lives of patients with rare disorders through innovative gene therapies.
Key Elements and Responsibilities
· Lead preparation meetings to define the strategy for source document structure and content
· Prepare and draft CMC source documents for use in global regulatory filings
· Ensure that CMC source documents are complete, accurate, and they comply with current regulatory requirements
· Prepare and coordinate the review and approval of CMC documents
· Collaborate with colleagues to interpret and summarize data, and support CMC regulatory strategy
· Drive the development, continuous improvement and maintenance of CMC documentation processes, best practices, and procedures
Experience & Knowledge
· Knowledge of eCTD structure and subsections, including appendices
· 3+ years working in the pharmaceutical industry, preferably in a biotechnology company, with emphasis on writing and drafting CMC source documents
· Experience in biologics and/or cell and gene therapy is preferred
· Proficiency in evaluating data, reviewing and creation of technical reports
· Experience in authoring documents for regulatory (FDA, EMA) review preferred
· Understanding of regulatory CMC requirements outlined in FDA, EMA and ICH regulations and guidelines would be beneficial.
Skills & Abilities
· An energetic self-starter with a sound scientific background and willingness to learn new skills and develop in an exciting and fast-paced environment
· Highly collaborative with effective interpersonal skills and excellent written and oral communication skills
· Detail oriented, with a strong focus on producing precise, high quality work
· Strong organizational skills and a continuous improvement mindset
· A highly motivated team player with demonstrated ability to work with technical personnel of different backgrounds
Education
· A minimum of a BSc in biological sciences, bioengineering, chemical engineering, analytical sciences, or a related field.
· Master’s degree and/or Technical/Medical writing credentials desirable.
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