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.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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