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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