Specialist, Technical Documentation And Data Analysis
hace 4 días
Broomfield
Job Description Specialist, Technical Documentation and Data Analysis - FDA, IVDR The Senior Associate, Technical Documentation and Data Analysis supports Research & Development and Regulatory Affairs by performing data analysis and authoring technical documentation for immunoassay in vitro diagnostic (IVD) products. This role contributes to design control documentation and regulatory submissions under IVDR and FDA frameworks, ensuring that all technical content is accurate, traceable, and compliant with applicable quality system requirements. The position is execution-focused and is ideal for an early-career professional with hands-on experience in regulated environments who is building deeper expertise in assay data analysis and regulatory technical writing, with strong opportunities for growth as the site expands its biobanking and FDA submission activities. Responsibilities • Draft, revise, and maintain high-quality technical documentation, including study protocols, validation and verification reports, stability reports, design inputs, and other design control deliverables for immunoassay IVD products., • Ensure all documentation is clear, consistent, scientifically sound, and compliant with internal quality procedures as well as IVDR and FDA requirements., • Incorporate feedback and technical input from Subject Matter Experts to ensure scientific accuracy and regulatory appropriateness of all documents., • Support the preparation of documentation for regulatory submissions, including IVDR Technical Documentation and FDA submissions, under the guidance of Regulatory Affairs., • Perform Excel-based analysis of assay performance data, including precision, accuracy, linearity, stability, and robustness studies., • Organize and analyze datasets, apply formulas and basic statistical calculations, and generate data tables, figures, and summary statistics for inclusion in technical reports and regulatory documentation., • Review datasets for completeness, consistency, and data integrity, and promptly flag potential data issues to R&D and Quality partners., • Work closely with R&D scientists, validation teams, Regulatory Affairs, and Quality to understand assay development activities and support documentation and data needs., • Participate in cross-functional discussions to clarify study designs, data requirements, and documentation expectations throughout the assay lifecycle., • Follow document control and quality assurance procedures to maintain version control, traceability, and compliance with regulated documentation standards, including CLIA-related documentation where applicable., • Manage multiple documentation and data analysis tasks in parallel, meeting defined timelines and prioritizing work based on project and regulatory needs., • Communicate clearly and professionally with cross-functional partners, providing updates, seeking clarification, and incorporating feedback in a timely manner., • Demonstrate proactive problem-solving and a results-driven approach by identifying documentation or data gaps and proposing practical, compliant solutions., • Bachelor’s degree in biological sciences, chemistry, biochemistry, biomedical engineering, or a related scientific discipline., • Typically 2–4 years of relevant experience in biotechnology, pharmaceutical, or in vitro diagnostics environments, or in technical/scientific writing in a regulated setting, or in assay development, validation, or stability testing support., • Hands-on experience contributing to or authoring regulated technical documentation in a quality-controlled environment., • Proficiency in Microsoft Excel, including data organization, formulas, basic statistical calculations, and creation of tables and figures for reporting., • Strong proficiency in Microsoft Word for authoring and formatting complex technical documents., • Working knowledge of Microsoft PowerPoint and Adobe Acrobat for preparing and reviewing technical and regulatory materials., • Clear and effective written and verbal communication skills, with the ability to translate complex scientific concepts into structured, readable documentation., • Strong attention to detail and commitment to data integrity, with the ability to identify inconsistencies or gaps in data and documentation., • Strong organizational and time management skills, with the ability to manage multiple tasks and projects with defined timelines., • Ability to work independently with routine guidance and review, taking ownership of assigned documentation and analysis tasks., • Collaborative and professional approach to cross-functional work, contributing constructively in interactions with R&D, Regulatory Affairs, and Quality teams., • Adaptability and comfort working in a fast-paced R&D environment with evolving priorities., • Confident, self-motivated, and self-directed work style, with strong follow-up skills and a proactive, solution-oriented mindset., • Experience with immunoassay in vitro diagnostic (IVD) products and related assay performance studies such as precision, accuracy, linearity, stability, and robustness., • Exposure to IVDR and FDA regulatory frameworks and familiarity with the structure and expectations of regulatory submissions., • Experience working within CLIA or similar regulated laboratory environments., • Background in assay development, validation, or stability testing support in biotechnology, pharmaceutical, or IVD settings., • Experience with document control processes and quality assurance practices in a regulated environment., • Demonstrated regulatory writing skills, including the ability to compile and present scientific data in a format suitable for regulatory review., • Strong interpersonal skills with a collaborative mindset, supporting effective teamwork across R&D, Regulatory Affairs, and Quality functions., • Results-driven attitude with the ability to prioritize tasks based on project impact and regulatory timelines., • Comfort working in a lean organization where individuals take ownership of a broad range of responsibilities and contribute to continuous improvement. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.