Sr. Manager, Regulatory Writing

Lawrence Harvey

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Job ID :

15039


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--California,Los Angeles Metro Area,


Key Skills :

Medical Writing, Pharmaceuticals, Regulatory


Salary :

Negotiable


Date Posted :

19 Jun, 2019



Company Name :

Lawrence Harvey


Location1 :

Los Angeles Metro Area




Job Category :

Medical Writing Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





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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