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Document Control Associate Consultant

Sage Therapeutics
Cambridge, MA
Start date
Feb 23, 2024

View more

Regulatory, Research/Documentation
Required Education
Associate Degree
Position Type
Full time
Genetown, Best Places to Work

Job Details

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a key role as a Document Control Associate Consultant that is responsible for organizing the lifecycle of documents in the electronic Document Management System as well as maintaining the Quality Systems archive of records stored both onsite and offsite.

Roles and Responsibilities

Maintain logs and document inventories to ensure traceability and chain of custody.

Oversee upload of records into the electronic Document Management System (eDMS), in compliance with regulatory requirements.

Support program efforts for certified copy creation, which includes scanning and reviewing records.

Provide support during internal and external audits as part of continuous improvement and inspection readiness.

Handle multiple tasks, take initiative, and independently follow through with responsibilities.

Perform additional responsibilities assigned by manager.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. The individual will need to be able to effectively communicate with various stakeholders and Quality Assurance team members at varying levels throughout the organization. The Document Control Associate will need excellent organizational skills and attention to detail, as well as be diligent and flexible.

Basic Qualifications

Associate degree

Must be able to lift 25 lbs.

Must be willing to work onsite 4 days a week.

Preferred Qualifications

1+ year applicable pharmaceutical/biotechnology industry experience and/or records and archive management preferred

Proficient with using MS Office (e.g., Word, PowerPoint, and Excel).

Expertise with Microsoft and Adobe products (e.g., SharePoint, Visio, and Acrobat Pro).

Experience working in an electronic Document Management System, including Veeva Vault Quality Docs.

Knowledge of GxP regulations, particularly pertaining to quality systems requirements.

Excellent communication skills (interpersonal, verbal, and written) and collaboration skills.

Experience building relationships and working with internal and external stakeholders.

Detail oriented and self-motivated.

Able to work effectively independently and as part of a team.

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

Excitement about the vision and mission of Sage.


Welcome To The Workplace With A Difference

Our vision is to fearlessly lead the way to create a world with better brain health – a vision we can only achieve with the help of our amazing team of highly knowledgeable, deeply passionate individuals.

At Sage, we believe that life is more than just a destination. We’re concerned with the journey, and we care deeply about everyone contributing to and benefiting from our own company journey. This means helping people discover the right path for them and carefully guiding colleagues along the way.

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Company info
215 First Street

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