Specialist Technical Writing AFP

Location: Thousand Oaks, CA
Date Posted: 09-15-2017
Day to Day Responsibilities:            
  • Provide document support for product registrations and global filings and analytical-related sections of INDs, CTAs, and CTDs and manuscripts.
  • Implement quality control for review and finalization of documents.
  • Ensure finalized documents are filed and archived appropriately.
  • Assist with process development initiatives to meet internal needs.
  • Keep abreast of regulatory requirements that affect work projects.
  • Collaborate with multidisciplinary teams across global regions.
The responsibilities of the Specialist-Technical Writing include:
  • Support subject matter experts in development of scientific and CMC documents that conform to global regulatory requirements, Amgen and industry standards, and accepted templates.
  • Manage review and approval of scientific and CMC documents intended to support regulatory submissions to include engagement of members of cross-functional teams to address and resolve issues in accordance with established timelines.
  • Ensure the accuracy, adequacy, and consistency of documents.
 The key activities for this role include:
  • Provide document support for product registrations and global filings and analytical-related sections of INDs, CTAs, and CTDs and manuscripts.
  • Implement quality control for review and finalization of documents.
  • Ensure finalized documents are filed and archived appropriately.
  • Assist with process development initiatives to meet internal needs.
  • Keep abreast of regulatory requirements that affect work projects.
  • Collaborate with multidisciplinary teams across global regions.
Basic Qualifications:
PhD
OR
Master’s degree and 2 years of industry experience
OR
Bachelor’s degree and 4 years of industry experience
OR
Associate’s degree and 8 years of industry experience
OR
High school diploma / GED and 10 years of industry experience
 
Preferred Qualifications:
  • Masters degree in chemistry, biochemistry, biology, or related field(s)
  • Experience in the preparation of analytical assessments to support the development of bio-similar candidates.
  • Experience in the development of bio-similar candidates.
  • Strong attention to detail.
  •  
  • Ability to discern areas of potential concern and communicate concerns effectively to manager.
  • Excellent written and oral communication skills and attention to detail
  • Proficient in Microsoft Office
  • Perseverance with a drive for results.
  • Ability to understand and apply regulations to a constantly changing environment.
  • Ability to effectively operate in an environment which requires negotiation, persuasion, collaboration, and analytical judgment.
  • Experience understanding and interpreting data and information and its practical application.
"This posting is for Contingent Worker, not an FTE"
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