Language

Sr Scientific Writing Specialist

Bioanalysis
GXP
Pharmacology
Pharmacokinetics
Toxicology
Drug Development
Clinical Documents
Pharmd
Preclinical
GLP
Clinical Pharmacology
Description:

Position - Temp - Sr. Scientific Writing Specialist
Pay Range - $50/hr - $60/hr
Location - Remote (US)
Duration - 6 months

 

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.

 

As a temp Sr Scientific Writing Specialist, a typical day may include:

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

 

To be considered for this role, you must have:

 

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



This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third-party solicitation.

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen
  • Preferred years of experience : No preferred years of experience required
  • Travel Required : No travel required
  • Shift timings: 9 AM to 5 PM
Job Location Remote
Pay USD 50.00 - USD 60.00 Per Hour
Contract Duration 6 month(s)