• Review written correspondence and artifacts to ensure final delivery is understandable
• Create documentation that meets regulatory requirements before distribution through the company to implement
• Work closely with colleagues across other departments to ensure everyone is completing and submitting the necessary documentation
• Act as the point of contact for retrieval of specific documentation
• Write, review, and update SOPs relating to documentation collection and storage
• Keep up to date with regulatory requirements around documentation and implementation changes
• Analysis of data submitted via documentation
• Take responsibility for the compilation of reports
• Dealing with long-term storage of information and data protection
• Participate in internal audits and external regulatory inspection
• Train colleagues on requirements around documentation
• Revise outdated documents and ensure that all staff are using the correct version

Skills: Document Review, Compliance, Collaboration, Retrieval, SOPs, Data Analysis, Reporting, Data Protection, Audits, Training, Version Control

• Audit client booking files for adherence to client-specific operating procedures
• Perform phone verifications with customers per client-specific operating procedures
• Understand and execute the home sale and refinance process
• Prepare and submit UCC filings to secure a purchase money security interest
• Image/index documents into the electronic imaging system
• Understand and navigate through the financial accounting system to complete basic post-book entries
• Review Amendments and understand how to process contract changes
• Understanding of various types of consumer Agreements
• Handle inbound consumer phone calls with the goal of one-call resolution
• Payment processing for current and/or delinquent accounts
• Provide professional oral and written communication with all internal and external customers
• Understanding of team and company-related goals
• Proactively identify and communicate process improvement ideas for the Documentation function and/or team
• Understand and adhere to Documentation procedures, team procedures, and the GreatAmerica Principles

Skills: Audit, Verifications, Sales Process, UCC Filings, Imaging, Financial System, Amendments, Agreements, Customer Service, Payments, Communication, Improvement, Procedures

• Develops creative designs and innovative ideas for client deliverables and adjusts reports in alignment with strict design rules. 
• Effectively creates layouts with strong typography and appropriate use of color, images, and fonts, allowing good readability. 
• Effectively utilizes styles, master pages, and templates. 
• Reviews and reworks report files to ensure that consistency is maintained and all rules from the report style guide are adhered to.
• Remains up-to-date with graphic software tools and equipment, such as PowerPoint (most important), Word, Excel, Photoshop, Illustrator, InDesign, Acrobat, etc. 
• Works with internal software add-ins to create tailor-made and brand-compliant output. 
• Maintains awareness of "state-of-the-art" techniques, equipment, best practices, and developments within the design community.
• Relates design work to the client's business needs and specific instructions.
• Understands, implements, and strictly adheres to the quality standards and procedures established by EY, including CDS standards and guidelines. 
• Follow established procedures to prepare and format client audit and tax documents
• Review document language and format to ensure quality output following compliance procedures
• Proof, edit, and format financial statements and other reports for final review and approval, complete and send to client and/or tax agencies on behalf of clients
• Prepare electronic copies of drafts, as well as print and collate draft copies for client meetings in a professional format when needed
• Converts documents, when necessary, from multiple formats

Skills: Design, Layouts, Consistency, Software Proficiency, Compliance, Innovation, Standards, Formatting, Proofreading, Client Design, Conversion

• Document formatting and processing using existing company boilerplates and following solicitation/contract requirements.
• Ensure accuracy and consistency of layout, styles, and requirements compliance.
• Track and route proposals and reports to reviewers and ensure timelines are met.
• Revise graphics in Illustrator, Photoshop, PowerPoint, or other graphics software, and insert and place graphics into documents.
• Partner with authors, editors, and graphic artists while maintaining text, document, and art version control.
• Provide cross-functional collaboration between internal teams including technical staff.
• File and organize/update network folders/archives.
• Support a physical records inventory and delivery project.
• Identify/locate physical records against the master inventory spreadsheet.
• Add physical records to file boxes and create a file box manifest.
• Scan records to verify completeness as a true copy, and upload a true copy to the electronic document management system.
• Ensure the master inventory spreadsheet is updated daily to reflect record inventory and delivery status.
• Process records identified for offsite storage at Iron Mountain.
• Use an electronic records management system (Veeva) to update record metadata.

Skills: Formatting, Consistency, Tracking, Graphic Editing, Version Control, Collaboration, Records Management, Document Management, Inventory, Storage Management

• Provide backup secretarial assistance for secretaries who are out of the office for medical/maternity leaves, extended vacations, or coverage for practice group secretaries, special tasks, or additional administrative assistance
• Assist secretaries, attorneys, and staff with overflow work and special projects. 
• Prepare/revise/redact documents, create Table of Contents/Table of Authorities, scan/convert documents, and create Word and PDF forms. 
• Transcribe handwritten notes and digital dictation. 
• Work in Excel, PowerPoint, Viewpoint, and Access databases.
• Perform Bates labeling and any other special projects as assigned within given deadlines. 
• Update client extranets as assigned. 
• Work on large non-billable and/or long-term projects.
• Provide needed support to other departments in the Firm and assist regional offices when requested. 
• Help answer phones and assist with document issues.
• Prepare PowerPoint presentations for Firm seminars and/or nametags for Firm events.

Skills: Secretarial Support, Document Prep, Transcription, Software Skills, Bates Labeling, Extranet Management, Project Management, Cross-Dept Support, Presentation Prep, Phone Support

• Responsible for maintaining all controlled documentation.
• Develop and maintain lines of communication between QA and other management teams to ensure that all are kept informed of any documentation issues and/or important changes in documentation.
• Be the point of contact for all documentation needs.
• Maintain Document Revision Requests and assist departments in the creation and/or revision of their controlled documents.
• Organize all documentation, such as SOPs, Forms, Logs, Training Modules, etc., for all departments.
• Ensure all documents are being sufficiently reviewed on a routine basis by the relevant departments, per the document review procedure and schedule.
• Assist each department in the creation of SOPs, Forms, Training Modules, etc. to ensure all departments have clear, concise, up-to-date documented processes.
• Maintain Document Control through the use of QMS Software, uniPoint.
• Operate within company policies and guidelines established in the quality and planning process
• Responsible for informing management of issues and gaining approval of the Manager, Quality Systems, and Compliance for any exceptions to policies in place, regarding Document Control.
• Be available to help in any company audits by providing access to controlled documentation on time.
• Provide support with Quality Management System software implementation and training.
• Utilize Document Control software and systems to ensure the most current revision of each document is readily available to all applicable employees within each department.
• Ensure that the employees involved in the document control process have the resources they need to create/revise documents.
• Responsible for maintaining all controlled documents per Document Control System, via Google Team Drives, Adobe DC Pro, and QMS software.

Skills: Document Control, Communication, Revision Management, SOP Creation, QMS, Compliance, Audit Support, Software Training, Document Organization, Process Docs

• Develop and maintain engineering control for all internal, incoming, and outgoing technical documents and processes, such as BOMs, Engineering Change Orders, Deviations, Engineering Change Requests, and various design documents using PLM/PDM systems.
• Process part, document, and assembly releases (electrical, mechanical, and firmware) and enforce the engineering workflow and documentation standards.
• Manage component and assembly manufacturing sources.
• Manages the routing, review, distribution and archival of new and revised controlled documents.
• Review and verify documentation for completeness, format, and compliance with requirements.
• Work with contract manufacturers and external suppliers to supply and manage the manufacturing documentation.
• Provide training to the appropriate departments on the documentation processes and specifications.
• Supports and adheres to the Company’s core values.
• Supports and adheres to the Company’s Code of Conduct and Ethics Policy.
• Represents the Company in a positive, professional manner when working with both internal and external customers.

Skills: Engineering Docs, PLM Systems, Document Processing, Manufacturing Management, Review, Supplier Management, Training, Compliance, Workflow, Archiving

• Document review and technical writing work experience
• Experience working in a GMP environment
• Experience with industry-leading PLM systems (Agile, Arena, Propel, Windchill)
• Experience writing, proofreading, and copyediting.
• Experience producing and organizing content with a logical flow
• Experience meeting multiple deadlines
• Understanding of general mathematical principles and calculations, at college entry level
• Understanding of cGMP and Safety regulations
• Excellent verbal and written communication skills in a regulated manufacturing environment
• The ability to work independently and in a team setting
• Ability to deliver high-quality documentation, paying attention to detail

Qualifications: BA in Information Management with 3 years of Experience

• Experience working in document control, quality systems, or similar experience
• Experience working in the medical device industry or similar regulated industry
• Highly organized and detail-oriented with strong follow-up skills to manage large volumes of documentation.
• Ability to understand and manage shifts in priorities.
• Excellent written and verbal communication skills.
• Proficiency in computer skills and Microsoft Word, Excel, Visio, and Adobe Acrobat.
• Basic knowledge of medical device Quality Management System regulations and standards including ISO 13485 and 21 CFR 820
• Experience with using eQMS (electronic QMS) systems
• A self-starter with strong interpersonal and organizational skills
• Demonstrated experience prioritizing conflicting demands in a fast-paced environment

Qualifications: BA in Library Science with 2 years of Experience

• Excellent track record in a Support or Support Operations role.
• History of comprehensive Zendesk solutions for a mid-level support team.
• Demonstrated use of SQL knowledge to enhance the reporting of a support team.
• Experience delivering cross-functional projects in a fast-paced environment.
• Experience authoring, publishing, and managing online/web content.
• Proven ability to understand and convey complex concepts/information to a variety of audiences with a wide range of technical aptitude
• Experience working autonomously, with minimal guidance, but willing to give, receive, and incorporate feedback.
• Experience prioritising, and building trust and relationships in a fast-paced and rapid growth environment.
• Python modeling and Looker dev experience
• Experience using Calendly, Guru, Looker, and Screenflow (or other desktop recording and editing software)
• Excellent verbal and written communication skills, elevated level of clarity and simplicity through written and visual forms.

Qualifications: BA in English with 6 years of Experience

• Experience working in a documentation environment.
• Experience with chemical or biological techniques
• Ability to work independently with minimal supervision after initial training on a process.
• Ability to multitask and manage time effectively to work in a fast-paced, dynamic environment.
• Able to be flexible and adaptable to unexpected changes in schedules and deadlines.
• Hands-on experience with SAP ERP systems and ISO13485 regulations
• Proficient with Microsoft Word, Excel, and PowerPoint.
• Experience working with statistics software.
• Strong verbal and written communication skills.
• Result-oriented with attention to detail

Qualifications: BA in Communications with 2 years of Experience

• Experience working in the scientific/healthcare field
• Experience in the use of eTMF system (e.g. clinical site, CRO, Sponsor, or clinical trial vendor).
• Comfortable with technology and ability to learn new systems quickly.
• Relevant experience in clinical research (clinical operations and/ or QA) or related fields.
• Exposure to current regulatory requirements and guidelines governing clinical research and GCP
• Working knowledge of MS Word, Excel, PowerPoint, and Outlook.
• Great attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines.
• Must be able to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization.
• Must be able to work in a fast-paced environment with demonstrated ability to appropriately prioritize competing tasks and demands.
• Ability to work proactively and successfully within a cross-functional team.

Qualifications: BA in Office Administration with 1 year of Experience

• Experience in document control, preferably supporting engineering projects.
• Knowledge of document and information management strategies, standards, policies, systems, and best practices
• Ability to read and understand technical documentation.
• The ability to partner building, relationship management, and collaboration skills to work effectively with project delivery units.
• Strong computer knowledge in EDMS, particularly in Microsoft SharePoint, PowerPoint, Word, and Excel.
• Knowing engineering software
• Verbal and written communication skills to prepare and present documentation, reports, proposals, and briefing materials.
• Analytical and problem-solving skills to manipulate, interpret, and present information in a simple and easily understood manner for a wide range of audiences.
• Bilingual (oral and written), with strong competencies for understanding technical information.
• Proven accuracy, reliability, and completeness in job accomplishment.
• The ability to handle multiple tasks at once
• Demonstrate autonomy, organization, attention to detail, rigor, and good judgment.

Qualifications: BA in Business Administration with 5 years of Experience

• Registered Nurse (RN), Doctor of Medicine (MD), Doctor of Osteopathy (DO) or foreign-trained physician required upon hire
• Adult acute care nursing experience
• Previous Ambulatory or Inpatient CDI experience
• Knowledge of Pathophysiology and Disease Processes
• Knowledge of Federal regulatory rules regarding documentation and coding specific to Risk Adjustment or Hierarchical Condition Category documentation and coding
• A good working knowledge of ICD-10-CM
• Strong organizational and analytical abilities, and able to manage multiple priorities and meet productivity targets
• Dependable with a demonstrated ability to efficiently and independently manage own time and tasks with minimal supervision
• Willingness to act and dress professionally at all times
• Excellent critical thinking, problem-solving, and deductive reasoning skills
• Strong computer skills – familiarity with Windows-based software programs, including Microsoft Office products
• Familiarity with electronic health records
• Ability to understand and communicate differences between Medicare Part B guidelines and Medicare Advantage and Risk Adjustment Coding and how they impact Hierarchical Condition Category assignment

Qualifications: BA in Office Administration with 7 years of Experience