Eileen Smits

FAQ About Eileen Smits

• What is Eileen Smits's address?

  Eileen Smits is located at
  Denmark

• What is Eileen Smits's job title?

  Eileen Smits is a
  Been engaged in the Pharmaceutical and Biotech industry since 1997 within Regulatory Affairs, Clinical Development, Clinical Operations, Business Development, Due Diligence, Quality Affairs and Document Management. Throughout the years, I have built up a large network in all areas, working with international teams. I am based in Denmark and having English as my mother tongue has always been a huge advantage Regulatory Affairs • Regulatory Compliance • Participated in various Authority Meetings (FDA, End of Phase II and EMEA, Scientific Advice, Pre MAA) • Submitted Clinical Trial Applications, Pediatric Investigational Plan ,eCTD submissions • EDMS systems Clinical Development/Operations support • Clinical Trials from start up to finalization • Clinical compliance • GCP • SOP writing, reviewing, training • Trial Master Files • CRO, BID meetings, Document Management between Sponsor and CRO • QC of Protocols, Clinical Trial Report Document Management, (Document Management Certified Professional) • eCTD template management and training • Document consistency across projects • Well-developed IT skills and flair for systems and processes Quality Assurance •Quality Management Systems (GCP, GMP) •Quality Management Reviews •Audits •SOP writing, reviewing, training Due Diligence •Alliance Management •Successful due diligence to acquisition of company •Team lead for Integration of RA and QA to new company Minervax

• What industry does Eileen Smits currently work in?

  Eileen Smits currently works in the
  Minervax

• What is Eileen Smits's area of expertise?

  Eileen Smits specializes in
  Been engaged in the Pharmaceutical and Biotech industry since 1997 within Regulatory Affairs, Clinical Development, Clinical Operations, Business Development, Due Diligence, Quality Affairs and Document Management. Throughout the years, I have built up a large network in all areas, working with international teams. I am based in Denmark and having English as my mother tongue has always been a huge advantage Regulatory Affairs • Regulatory Compliance • Participated in various Authority Meetings (FDA, End of Phase II and EMEA, Scientific Advice, Pre MAA) • Submitted Clinical Trial Applications, Pediatric Investigational Plan ,eCTD submissions • EDMS systems Clinical Development/Operations support • Clinical Trials from start up to finalization • Clinical compliance • GCP • SOP writing, reviewing, training • Trial Master Files • CRO, BID meetings, Document Management between Sponsor and CRO • QC of Protocols, Clinical Trial Report Document Management, (Document Management Certified Professional) • eCTD template management and training • Document consistency across projects • Well-developed IT skills and flair for systems and processes Quality Assurance •Quality Management Systems (GCP, GMP) •Quality Management Reviews •Audits •SOP writing, reviewing, training Due Diligence •Alliance Management •Successful due diligence to acquisition of company •Team lead for Integration of RA and QA to new company

• Which languages does Eileen Smits speak? 

  Eileen Smits speaks the following languages:
  No languages available.

• Which industries has Eileen Smits previously worked in?   

  Eileen Smits has prior experience in the following industries:
  Azanta As Acquired By Norgine , Norgine Sverige AB , Norgine Sverige AB , Leo Pharma , Symphogen A/S , Ferring Pharmaceuticals , RheoScience , Novo Nordisk

• What is Eileen Smits’s work experience?  

  Eileen Smits has the following professional experience:
  Minervax , Azanta As Acquired By Norgine , Norgine Sverige AB , Norgine Sverige AB , Leo Pharma , Symphogen A/S , Ferring Pharmaceuticals , RheoScience , Novo Nordisk .

• How can I find Eileen Smits on LinkedIn?  

  You can view Eileen Smits’s
  LinkedIn profile at LinkedIn URL.

• What are Eileen Smits’s work email addresses?  

  Eileen Smits’s work email addresses are
  [email protected] .

• What company does Eileen Smits work for?  

  Eileen Smits works at
  Minervax