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Title: Sr. Scientific Writing Specialist

Schedule: M-F Full Time

Type: Contract

Responsibilities:

+ Drafts and manages reviews of submission documents for a single functional area (nonclinical pharmacology, preclinical pharmacokinetics, toxicology, quality, clinical bioanalysis, or clinical pharmacology).

+ Prepares eCTD tabulated summaries, participates as a viewer in the drafting of the eCTD written summary, and may participate in comment reconciliation.

+ Updates and maintains document templates and internal guidance documents. May prepare and/or review manuscripts for publication.

+ Independently author nonclinical/quality/clinical documents for submission to health authorities worldwide

+ Prepare and/or reviews manuscripts for publication

+ Participate in the revision and maintenance of document templates or shells

+ Adhere to timelines for document preparation

+ Abide by and keep current with GxP and regulatory guidelines and all company SOPs or working practices pertinent to the position

+ Simultaneously advance multiple projects as assigned

Requirements:

+ Bachelor’s degree or MS/PhD/PharmD in a life science

+ 0-2 years of scientific writing experience

+ Computer proficiency (Word, Excel, Adobe, and related software) and fluency in the English language is required

+ Basic understanding of the eCTD and the drug development process is a plus, as is GLP experience

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.