Senior/Principal Scientist/Assoc. Director Clinical Research Group

Clinical Research and regulatory documentation Domain Expertise

• Regulatory submission expertise across CTD/eCTD formats - deep familiarity with the Common Technical Document structure (Modules 1-5) and how CMC (Module 3), nonclinical/toxicology (Module 4), and clinical (Module 5) sections fit together.
  
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  Experience preparing submissions for FDA (NDA/BLA/ANDA), EMA, and other ICH-aligned agencies.
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• Hands-on experience drafting or reviewing CMC sections (drug substance/ product specs, stability, manufacturing)
  
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  Hands-on experience in nonclinical toxicology reports/summaries and understanding submission gaps.
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• -Working knowledge of ICH Q (Q1-Q14), S (S1-S12), E (E1-E20), and M (M4, M8) guidelines (ICH guideline fluency (Quality, Safety, Efficacy series) ) and the format and content expectations across US/Europe and Asian markets.
  
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  Track record supporting drug expansion into new regulatory jurisdictions (US, EU, and others), including gap analyses between regional requirements and adapting dossiers accordingly.
  

Product Development Support

• Provide subject matter expertise on clinical trials, drug development, and clinical research processes to the Science, AI, Data Science, and Software Engineering teams to develop clinically relevant products and features.
  

• Support the design, development, validation, and enhancement of clinical research products and platforms.
  

• Review and validate clinical workflows, protocols, study designs, and research methodologies used in products and customer solutions.
  

• Provide insights on industry trends, regulations, and best practices in clinical research.
  

• Provide expert knowledge for the development of algorithms, data models, and clinical decision-support applications.
  

Customer Solutions & Consulting

• Work with customer-facing teams to understand client requirements and provide clinical expertise.
  

• Support solution design, demonstrations, presentations, and proposal development.
  

• Assist in addressing clinical and scientific queries from customers.
  

• Participate in customer workshops and stakeholder discussions.
  

Qualifications and Work Experience

• PhD/MSc in Pharmacy, PharmD, Life Sciences, Biotechnology, Medicine, Clinical Research.
  

• Experience working for Pharma or CRO companies in clinical trial design and documentation group and/or Medical Affairs team.
  Relevant certifications - credentials such as RAC (Regulatory Affairs Certification from RAPS), a regulatory affairs/medical writing certification (e.g., AMWA, DIA), or an advanced degree (PharmD, PhD in life sciences) combined with 8-10+ years in regulatory writing/CMC-toxicology documentation.
  

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