Senior Technical Writer, Commercial Supply Chain at Atrium Staffing (consultant) (2025-10 – Present)
Create clear and concise documentation as a ghost writer detailing the processes, procedures, and systems involved in Commercial Supply Chain, collaborating with cross-functional teams and stakeholders to effectively manage inventory, logistics, and product flow.
- Write comprehensive operational procedures, work instructions, standard operating procedures (SOPs), and training materials for various supply chain activities such inventory management, order fulfillment, shipping, receiving, and quality control.
- Create technical data specifications (TDSs) for raw materials/consumables used in the manufacturing process.
- Develop user manuals for supply chain management systems and software describing functionalities and navigation for end users.
- Design and write training materials for supply chain processes, including presentations, e-learning modules, and hands-on exercises.
- Update, revise, and proofread existing documentation for clarity, accuracy, and consistency to reflect changes in processes and system updates ensuring adherence to regulatory requirements for GxP, GDP (Good Distribution Practices), GCP (Good Clinical Practices), and ICH (International Council for Harmonisation).
- Manage and resolve current and overdue Periodic Reviews (PR) by collaborating with doc owners, document revisions, conducting office hour meetings, and tracking PR tasks and due dates.
Technical Writer II/Project Manager - Pharmacovigilance at Alpha Consulting (consultant) (2025-01 – 2025-10)
Collaborate and lead a team of SMEs, business process owners, key stakeholders, and customers in the process, development, revision, implementation, and maintenance for process enhancement and continuous improvement for procedural and instructional documentation content development for NAO (North American Operations) Patient Safety Training Development & Documentation and CMR (Clinical Development, Medical & Regulatory Affairs) Training & Knowledge Management.
- Create, edit, and author content for SOPs, instructions, guidance documents and training decks in Veeva QualityDocs System to meet global regulations (GCP, GxP, and ICH), is inspection ready for regulatory submission and meets regulatory requirements, and designed with operational effectiveness to support corporate compliance.
- Evaluate global documentation against evolving industry/regulatory requirements, audit/inspection findings, business needs, higher level corporate policies, client feedback and trends, and make recommendations for changes when necessary.
Project Manager/Technical Writer at Piper Companies (consultant) (2022-05 – 2024-07)
Serve as PM and Lead Tech Writer leading a team of 3-5 tech writers for the Documentation Workstream on the following projects: B160 Flash Project - implementation of new manufacturing facility for production of TICE BCG for bladder cancer treatment. One Durham Initiative - approach to evaluate similar/like SOPs from other buildings and departments to align and combine into one Durham Site SOP in an effort to reduce SOPs with duplicate content.
- Initiate, create, and update B160 Doc Tracker excel spreadsheet for SOPs to track status updates, review and approval workflows, and target vs. actual approval/effective dates to meet project deliverables, and align with project timeline and milestones.
- Ensure cohesion and coordination between tech writer team and across workstreams to align with changing SOP target dates.
- Author, create, and edit Building 160 documentation for DS (Drug Substance), DP (Drug Product), Equipment, Alarms, Sampling & Lab testing, Manufacturing, Logistics, Operations, IT, and C&Q (Commission & Qualification) ready documents, which include Document Change Controls, SOPs, work instructions, job aids, forms, and process flow diagrams.
- Route docs for review and approval workflows to assigned SMEs and enter proposed effective dates in Veeva Vault QualDocs system.
- Collaborate with Learning and Development team to determine training needs and create training content.
- Communicate and follow-up via Teams chats; coordinate and conduct meetings with tech writer team, management, workstream leads, and key stakeholders to discuss SOP status updates, SOP issues, and escalate SOPs at risk of not meeting target effective dates.
- Conduct one-on-one meetings to engage, listen, and communicate with tech writers, help resolve SOP issues, and provide feedback.
Project Manager - CAR-T Cell Therapy Manufacturer at Bristol-Myers Squibb/Celgene (2021-01 – 2022-03)
Facilitate, advise, and guide business planning, process governance, and portfolio decision-making for the Quality group in partnership with the PMO Group and Site Leadership to align with the BMS Network and initiatives for clinical and commercial manufacturing of Breyanzi for lymphoma and Abecama for myeloma.
- Collaborate and work with cross-functional departments, SMEs, stakeholders, business process owners, and project teams to define and establish project timelines and key milestones, resource requirements and constraints, and scope of project.
- Develop and maintain Quality Project Portfolio Dashboard and Master Project list in Smartsheets, and create project timelines and Gantt charts to ensure visibility of project tracking of deliverables and activities.
- Research, organize and gather project status updates/progress utilizing Smartsheets, SharePoint, PowerPoint, Veeva/Celdox, and Infinity Quality Risk Management System.
- Project Manager to support the following projects: Implementation/validation of QC Micro Growth Direct Equipment; RFT (Right First Time) Initiative for Deviation Reduction; Material Non-Conformance Electronic Integration with LIMS/CELabs
Project Manager (YOH contractor) at Sanofi Pasteur (2020-06 – 2020-10)
Serve as PM to support the implementation/validation of equipment and licensure for three projects: Building 79 for new vaccine manufacturing facility; Drug substance bags for Buildings 37 and 59; Centrifuge replacement for Building 37.
- Interface with Project Leader, Project Scheduler and team members as necessary to develop and initiate project request, initial project resource, and estimates (using standard sanofi pasteur tools and guidelines).
- Identify deliverables, resources, budget costs, strategies and testing plans, and MS project schedule with appropriate milestones.
- Maintain action plans, decision logs, and risk mitigation plans; follow up with team members for status updates.
Technical Writer II (ProUnlimited contractor) at Sanofi Pasteur (2018-04 – 2020-04)
Responsible for technical writing, developing, formatting, updating and editing of SOPs, SWIs, process flow charts, job aids, validation protocols and reports (drug substance, drug product, lab, manufacturing, specifications, IQ, OQ, & PQ) for the Building 79 project for the manufacture of Influenza vaccine in accordance with GMP/GxPs and regulatory requirements.
- Support Change Management team as Change Control Leader for Building 79 project to initiate change controls in electronic quality system (Phenix) and track progression through assessment and approval process. Update process of action items and close-out as completed by technical owners.
- Utilize Quality eDoc system/Geode+ and MS Word to author, edit, update, and review documentation to meet required timeframes.
- Communicate, correspond, and meet to establish working relationships with support team, production team members, SMEs (subject matter experts), and stakeholders in order to gather all necessary information, recommend and suggest ways to improve the process and flow
