12 Writing jobs in Highland Falls
Sr. Scientific Writing Specialist
10591 Tarrytown, New York
System One
Posted 9 days ago
Job Viewed
Job Description
Job Title: Sr. Scientific Writing Specialist
Type: Contract
Compensation: $55 - $57 hourly
Contractor Work Model: Remote
Hours: 8 AM- 5 PM M-F
Responsibilities:
Help with drafting and handling reviews of submission documents for nonclinical pharmacology. In this exciting role you will prepare eCTD tabulated and written summaries, nonclinical pharmacology study reports, and participate in comment reconciliation.
+ Independently author nonclinical documents for submission to health authorities worldwide
+ 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:
+ PhD with 0-2 years of scientific writing experience (Preferred) BS/MS biology, biochemistry, life science background/education with 5-7 years experience
+ Non clinical writer for reg submission documents, non clinical pharmacology
+ Module 2 or Investigative Brochures (nonclinical components)
+ Supporting Pharmacology, protein therapeutics groups
+ Computer proficiency (Word, Excel, Adobe, and related software)
+ Fluency in the English language is required.
+ Basic understanding of the eCTD and the drug development process is a plus, as is GLP experience
+ Have Computer proficiency (Word, Excel, Adobe, and related software) and fluency in the English language is required
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.
#M-
#LI-
#DI-
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.
Type: Contract
Compensation: $55 - $57 hourly
Contractor Work Model: Remote
Hours: 8 AM- 5 PM M-F
Responsibilities:
Help with drafting and handling reviews of submission documents for nonclinical pharmacology. In this exciting role you will prepare eCTD tabulated and written summaries, nonclinical pharmacology study reports, and participate in comment reconciliation.
+ Independently author nonclinical documents for submission to health authorities worldwide
+ 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:
+ PhD with 0-2 years of scientific writing experience (Preferred) BS/MS biology, biochemistry, life science background/education with 5-7 years experience
+ Non clinical writer for reg submission documents, non clinical pharmacology
+ Module 2 or Investigative Brochures (nonclinical components)
+ Supporting Pharmacology, protein therapeutics groups
+ Computer proficiency (Word, Excel, Adobe, and related software)
+ Fluency in the English language is required.
+ Basic understanding of the eCTD and the drug development process is a plus, as is GLP experience
+ Have Computer proficiency (Word, Excel, Adobe, and related software) and fluency in the English language is required
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.
#M-
#LI-
#DI-
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.
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