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Sage Therapeutics Document Assistant, TMF in EMAIL: Workday@Sagerx.com, Massachusetts

General Scope and Summary

SAGE Therapeutics is searching for a Trial Master File (TMF) Document Assistant to process study documents in the TMF. This FTE role will require the candidate to be highly motivated to learn the TMF and document processing standards, as well as have a willingness to collaborate with cross-functional teams.

Roles and Responsibilities

  • Responsible for document filing and maintenance.

  • Follow the TMF file structure regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices, and the TMF Reference Model.

  • Ensure that all new and updated record information is accurately entered in the appropriate records management databases, such as eTMF Veeva Vault, for inspection readiness and highest quality of document governance.

  • Follow company eTMF SOPs, processes, and data structure.

  • Assist Clinical Operations in tracking that essential documents are received and maintained across assigned studies.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop trusting relationships, and good conflict management and negotiation skills.

Basic Qualifications

  • High School diploma required.

Preferred Qualifications

  • Attention to detail and the willingness to learn document processing standards.

  • Embrace our Core Values: Put People First, Improve Lives, Forge New Pathways, Cultivate Curiosity, and Do Right.

  • Excitement about the vision, mission, and therapeutic focus of Sage.

Employment Type:

Employee

Number of Openings:

1

Job ID:

R001075

#Biotechnology #Careers #ThisIsSage

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEO is the Law - Poster Supplement

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

Protected personal characteristics include: age, race, ancestry, color, sex, national origin, sexual orientation, gender identity or expression, religious creed, mental or physical disability, pregnancy, genetic information, marital or civil union status, participation in the uniformed services of the United States, or any other characteristic protected under applicable federal, state or local law. To learn more, see Sage's Anti-Harassment and Equal Opportunity Policy

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