Full-time Position
Position Overview:
Genetworx, a fast growing Clinical and Molecular diagnostic laboratory, is searching for a competent and experienced Senior Technical Writer to join our team. In this role, the successful applicant will have the scientific knowledge and writing expertise to effectively communicate technical and scientific medical information. Document audiences include regulatory authorities, clinical study sites, and thought leaders in involved in clinical testing and research and development. The position’s focus includes clinical documents such as validation protocols, IRB Protocols and clinical study reports (CSRs) and regulatory submissions. This will entail some project management and leadership, working closely with internal team members to ensure the documents are high quality and completed in a timely fashion, compliant with SOPs, FDA and CGP guidelines, CLIA/CAP requirements, and company goals. The core responsibilities of the Senior Technical Writer, Research and Development are listed below. This is an exciting opportunity to join a dynamic test lab. If you have a strong background in technical writing and have a great attitude, we greatly encourage you to apply.
Responsibilities:
- Write, edit and collaborate on development of preclinical, clinical, and sections of regulatory documents (e.g., Clinical Validation protocols, IRB Protocols, clinical study reports, marketing materials.
- Compile, write, and edit documents covering all phases of clinical research, to include integrated summaries of data, risk/benefit analysis, etc
- Organize and assist in filing FDA documentation
- Assist in the analysis, synthesis and presentation of complex information for scientific presentations
- Distill large amounts of clinical and scientific data into essential elements for graphical display.
- Formulate key messages from clinical study data
- Perform literature-based research to support writing activities
- Provide QC review support as needed and ensure consistency between related documents
- Understand the levels of evidence required to achieve regulatory and clinical trial goals.
- Ability to coordinate, plan, and manage communications to enable timely review from other authors and reviewers and to function as a collaborative team member
- Create and maintain document timelines incorporating client team input
- Develop and maintain medical writing processes, SOPs, templates, and outlines for key documents
- Maintain an awareness of current industry practices and regulatory requirements that affect medical writing
- Keep abreast of current literature, emerging science, technological developments, and medical trends
Minimum Requirements:
- BS, MS, PharmD, or PhD in a scientific or medical discipline with relevant experience
- 5+ years’ experience in the clinical/regulatory writing and editing
- Basic to intermediate knowledge of biostatistical and clinical research concepts
- Thorough understanding of FDA and CLIA/CAP regulations and guidelines, and AMA editing standards
- Experience authoring/editing CSRs and other types of clinical regulatory documents (e.g., clinical protocols, Investigator’s Brochures)
- Proven ability to implement medical writing processes and standards
- Knowledge of Microsoft Office applications, document templates, and electronic document management systems; proficiency in Word, Excel, PowerPoint, email, and the Internet
- Willingness and ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment; adapts to changing deadlines and priorities
- Ability to work collaboratively to coordinate the efforts of team members to complete deliverables
- Exceptional oral and written communication skills
- Flexible, adapts work style to meet organization needs
- Motivated, self-directed and able to work autonomously and in team settings to meet aggressive organizational goals
- Experience working with FDA submission documentation is an asset
- Experience working with Clinical Trial documentation is an asset
Benefits:
We offer medical, dental and vision coverage, a 401(k) plan, paid holidays, paid vacation, sick time and an employee bonus program.
Physical Demands: While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands to finger, handle or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move objects up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision and the ability to adjust focus.
Travel: Work related travel will be minimal.