About the role
Reporting to the Director, Quality Management Systems, the Document Control Manager will focus on the creation, revision, management, and retirement of Quality Systems documents within the eDMS, and managing controlled records, including historical records, within the controlled library.
Responsibilities:
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.
Qualifications:
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; ability to create and correct Styles in Word strongly preferred
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
About Us:
Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.
The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.
Celcuity is an Equal-Opportunity Employer.
Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $100,000 - $120,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.
Originally posted on Himalayas