TSRI Life Sciences Careers

TSRI Life Sciences is seeking qualified, experienced Submission Specialist. The successful candidate will be capable of working on multiple projects with a minimum of supervision and meet established timelines.

JOB SCOPE

The qualified applicant will possess the following:

Associate degree with 5-7 years experience or Bachelor degree in Computer Science, Project Management or related field.
3-5 years experience in regulatory publishing and submission compilation.
Familiar with ICH and FDA Guidance's.
Thorough understanding of FDA regulatory guidelines.
Project management experience a plus.
Technical Proofreading and detail-oriented skills.
Expertise using MS Word and Adobe Acrobat products and plug-ins such as ISI Toolbox.
Ability to create and validate bookmarks and hyperlinks.
eCTD compilation experience desired.

RESPONSIBILITIES

Additional responsibilities associated with this position are as follows:

Publish non-clinical, Clinical and regulatory submission documents with eCTD standards.
Maintain knowledgebase to provide technical support.
Help resolve technical publishing issues for Documents Publishing and submission compilation groups.
Assist with template administration.

	REGULATORY SUBMISSION MANAGER - EAST COAST Excellent opportunity for experienced candidate knowledgeable with eCTD publishing. Advanced technology experience is a plus. Seeking candidates with a minimum of 5 years+ experience.

	SUBMISSION SPECIALIST - MIDWEST & WEST COAST Seeking experienced candidate for publishing clinical and non-clinical regulatory submission documents in eCTD format.

	CLINICAL DATA MANAGER - EAST COAST Thorough understanding of clinical trial methodology, ICH, GCP, and medical terminology.

	DRUG SAFETY SPECIALIST Seeking experienced candidate with knowledge of U.S. and non-U.S. regulatory requirements.

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