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Cirkul Inc
Watertown, MA, United States
What is Cirkul? Cirkul is a rapidly growing beverage technology company on a mission to make a healthier world by helping people enjoy drinking more water. The team at Cirkul developed an innovative beverage delivery system that makes drinking more water delicious, fun, and personalized. The technology reduces the shipping weight of bottled bever
Job Source: Cirkul Incbluebird bio, Inc.
Somerville, MA, United States
HOW YOU'LL FLY You'll help to bring more patients their bluebird days by: Oversee eTMF (electronic Trial Master File) creation, maintenance, and archiving, ensuring each are performed in accordance with Standard Operating Procedures (SOP), ICH-GCP Guidelines, EMA, FDA, and other appropriate regulations. Contribute to the integrity, completeness, an
Job Source: bluebird bio, Inc.Pyramid Consulting
Boston, MA, United States
Immediate need for a talented Document Controls Record Management. This is a 15+ Months contract opportunity with long-term potential and is located in Marlborough, MA(Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID: 23- 40501 Pay Range: $40 - $43/hour. Employee benefits include, but are no
Job Source: Pyramid ConsultingPSG Global Solutions
Cambridge, MA, United States
Description We're looking for a Document Coordinator , working in Pharmaceuticals and Medical Products industry in 300 Third Street, Cambridge, Massachusetts, 02142, United States . Maintains metrics for periodic review Makes updates in Veeva based on doc owner response Communicates with and assist end users understanding process and holdi
Job Source: PSG Global SolutionsKeolis North America LLC
Somerville, MA, United States
At Keolis Commuter Services (KCS) , we give every team member-and their ideas-a seat for the journey. We are a diverse team made up of different backgrounds, stories, and perspectives, which is our strength. If you're looking for a career with a company that invests in your future, KCS is the place for you. We Imagine. We Care. We Commit! Since 2
Job Source: Keolis North America LLCPSG Global Solutions Careers
Cambridge, MA, United States
Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Document Coordinator , working in Pharmaceuticals and Medical Products industry in 300 Third Street, Cambridge, Massachusetts, 02142, United States . Maintains metrics for periodic review Makes updates in Ve
Job Source: PSG Global Solutions CareersGlobal Channel Management
Lynnfield, MA, United States
Job Description: Document Prep needs 1+ years' experience Document Prep requires: Admin support Clerical Document prep Will train Document Prep duties: Read a Work Order with all the processing instructions. Break down documents utilizing and human readable barcode that will identify the breaking points for each mailing package Fold and inser
Job Source: Global Channel ManagementGlobal Channel Management
Lynnfield, MA, United States
Job Description: Document Processing needs no experience Document Processing requires: Ø Interview times M-F 4-5p Ø Ability to lift up to 20-40 pounds (boxes and mail trays). Ø No Experience needed, will train. Document Processing duties: Ø Handles Banking and Insurance Documents to be mailed to the Customers via USPS, FedEx, UPS, and Specia
Job Source: Global Channel ManagementBoston, MA, United States
Company Overview
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary:
Reporting to the Senior Director of Safety Assessment, we are seeking an experienced, motivated, and highly organized individual with an outstanding attention to detail to assist with the management of document-related activities supporting Technical Operations (Tech Ops). Your key responsibilities include developing and administering best processes and practices for document oversight and documentation compliance across Cerevel's portfolio. Additional responsibilities include cross-functional interactions supporting accurate and timely health authority/regulatory submissions across Cerevel's portfolio. Occasional travel to the Cerevel office may be required for business needs. You will be expected to work independently with minimal supervision, cooperatively, and efficiently within a fast-paced environment with multiple timelines. This position will also provide you with opportunities to learn more about and directly contribute to the drug development process as we bring these much-needed therapies to patients.
Key Responsibilities
* Manage controlled documents in Veeva Vault Quality Docs (vQD) for programs: drafting documents, maintaining metadata, linking supporting documents, maintaining revision control as needed
* Support generation, review, and submission of eCTD Module 3 documents
* Serve as group liaison/representative with key functional groups (eg, Global Product Quality)
* Conduct detailed document reviews to ensure accuracy and completeness, including quality control (QC) reviews against source documents
* Identify and support process improvement initiatives
* Ability to build relationships and work collaboratively with Tech Ops subject matter experts to actively track and confirm deliverables to ensure timely generation of high-quality documents
Required Qualifications
* Minimum of 7-10 years of relevant document control experience in the biotechnology or pharmaceutical industry or in a manufacturing setting; hands-on experience with vQV or equivalent electronic document management system
* Prior authoring of eCTD Module 3 sections supporting regulatory submissions
* Relevant industry experience in CMC-related scientific writing, QC activities and processes in a regulated (GMP-compliant) environment including batch production records, manufacturing procedures
* High attention to detail and aptitude for change agility; successful management of multiple concurrent activities
* Excellent communication (both oral and written), facilitation, and interpersonal skills with demonstrated ability to manage timelines and generate quality work while using these skills in a cross-functional team setting
* Exercise good judgement in elevating and communication issues to line management; contribute to problem solving and resolution
* Thrives in a dynamic, fast-paced environment with the capacity to successfully complete tasks independently in a remote start-up environment
* Acts with integrity and respect always
Desired Quaifications
* Strong scientific background in analytical and/or pharmaceutical sciences preferred
* Prior group or team management experience
* Proficient in the use of Veeva Systems, Microsoft Office products (Word, Excel), Adobe Acrobat, SmartSheet, and creating/utilizing structured document templates
* Working knowledge of regulatory guidances and eCTD requirements for NDAs, INDs, CTAs, IMPDs, etc.
Education
* B.S. / M.S. or equivalent in analytical or pharmaceutical sciences or other scientific discipline
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
Manager, Document Management jobs in Boston, MA, United States
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