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Sr. Manager, Regulatory Writing

Sr. Manager, Regulatory Writing

Job Title: Sr. Manager, Regulatory Writing
Contract Type: Permanent
Location: Los Angeles Metro Area, California
Industry:
Salary: Negotiable
Reference: KMRegWriter_1526507149
Contact Name: Kyle Murfin
Contact Email: k.murfin@sciproglobal.com
Job Published: May 16, 2018 22:45

Job Description

The Senior Manager, Regulatory Writing will report to the Director of Regulatory Writing. The regulatory writer will be responsible for writing and/or editing clinical documents for INDs, BLAs, MAAs, and associated regulatory submissions.

Roles and Responsibilities (including, but not limited to):

  • Serve as medical writing lead for clinical trial-related regulatory documents
  • Write/edit/review content of clinical trial-associated documents for new and ongoing programs
  • Work with cross-functional teams to ensure production of high-quality written documents
  • Perform literature searches as needed, and summarize data for incorporation into documents
  • Adhere to Kite Style Guide, templates, and SOPs for document development
  • Perform QC checks on document content
  • Commit to company timelines for all assigned documents
  • Manage/coordinate contributions from contract writers


Requirements:

  • MS/MA +6 years regulatory writing or relevant experience required
  • Ph.D. preferred with 3-5 years' experience in regulatory writing or equivalent experience
  • Experience with clinical trial protocols, investigator's brochures, clinical study reports, safety narratives, other safety reports, or CTD clinical summaries
  • Knowledgeable of US and international regulations
  • Strong scientific background in cellular immunology or related field, or oncology, is a plus
  • Demonstrated advanced writing skills, with a strong command of English language and grammar
  • Proficiency in MS Office Suite, Endnote, and MSWord templates
  • Strong oral and written communication skills
  • High attention to detail
  • Efficient, organized, and able to handle short timelines in a fast-paced environment
  • Ability to work both independently and collaboratively
  • Ability to identify issues and propose solutions

NOTE: This position can remote.

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