Document Control Manager

November 18

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $85k - $125k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Celcuity

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Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Facilitates the meticulous creation, revision, and retirement of controlled documents in the eDMS, including managing and tracking Document Change Control workflows and participants. • Management and migration of legacy files into the eQMS. • Coordinates with the Training Admin to create new or revisions to Training Requirements, learners, quizzes, and other training related to controlled documents. • Helps eDMS users with the how-to of document creation and revision and works with the QMS Admin to keep relevant document control SOPs and Work Instructions up to date. • Helps eDMS users find and use current effective documents. • Facilitates meetings with the QMS Admin and document reviewers to complete content creation or revisions. • Manages GxP record retention and destruction tasks. • Facilitates Certified Copy creation and retention. • Other duties as assigned.

🎯 Requirements

• Bachelor’s degree in the life sciences, chemistry, or related field; or relevant experience. • Five plus (5+) years of experience in document control in a pharmaceutical company, or a related area. • Proficiency and experience with electronic document management systems, Veeva strongly preferred. • Knowledge of version control practices and document lifecycle workflows. • Familiarity with industry standards such as FDA 21 CFR Part 11, ISO 9001, GMP. • Strong attention to formatting, process, and metadata tagging. • Document auditing and compliance tracking capabilities. • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels. • Strong interpersonal skills for interacting with employees and leaders across various levels and functions. • Attention to detail and ability to manage multiple processes and documentation requirements. • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint. • Ability to work in a team or independently as required. • Outstanding organizational skills with the ability to prioritize. • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment. • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization. • Flexible and willing to learn; adapting to business and site needs in a dynamic environment. • Maintain a positive, approachable, and professional attitude.

🏖️ Benefits

• medical, dental, vision insurance • 401(k) match • PTO • paid holidays