Kelly Science and Clinical FSP is currently seeking a Medical/Technical Writer for a long-term engagement in Cincinnati, OH with one of our Global Medical Device clients. This role is hybrid and onsite 1-2 days a week. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full-benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Medical/Technical Writer, Scientific Research
Location: Cincinnati, OH / Remote Hybrid We are seeking a skilled Medical/Technical Writer to support our scientific research (preclinical, clinical, medical) and regulatory documentation efforts. The ideal candidate will bring expertise in authoring complex scientific documents, managing document workflows, and the management of Artificial Intelligence tools in the writing process. This role involves collaborating across cross-functional teams to ensure compliance with regulatory standards and internal SOPs and driving documentation process improvements.
Key Responsibilities: - Develop, review, and finalize a wide range of scientific and regulatory documents including, but not limited to, scientific protocols and reports, post-operative evaluations, Quality audit edits and responses, responses to regulatory agencies, and IACUC documents.
- Perform literature searches to support research activities, IACUC documentation, and publications.
- Support the deployment and integration of AI-enabled authoring and review tools, ensuring alignment with regulatory standards and internal SOPs.
- Maintain current knowledge of emerging AI technologies, regulatory guidance, and industry best practices related to preclinical documentation.
- Assist in the rollout of writing digital tools and platforms, ensuring seamless adoption and integration across teams.
- Coordinate user acceptance testing (UAT), troubleshoot technical issues, and collaborate with IT teams to optimize document management systems and other digital tools/platforms.
- Lead or actively participate in process working groups, providing strategic input to enhance document development workflows.
- Develop and deliver comprehensive training materials for end-users, promoting best practices in document creation and review.
- Monitor system performance, gather user feedback, and recommend enhancements for continuous improvement.
- Ensure all documentation complies with current regulatory standards, industry guidelines, and internal SOPs.
- Support change management activities.
- Complete all required project tracking, metrics reporting, and training documentation within company systems.
- Foster strong, collaborative relationships with cross-functional teams including R&D, Regulatory Affairs, IT, and Quality Assurance.
Qualifications & Requirements: Education: Bachelor's degree in a scientific discipline or in English or Journalism with appropriate technical /medical background or certification; advanced degrees (Masters, PhD, MD) are preferred.
Experience: - Minimum of 3 years of relevant scientific experience, with a strong background in preclinical and/or clinical research or related fields.
- At least 2 years of experience in scientific or medical writing within the preclinical, clinical, and/or regulatory domain.
Skills: - Proven expertise in authoring and managing complex scientific documents and regulatory submissions.
- Familiarity with the document landscape in scientific research and regulatory submissions.
- Experience with digital transformation initiatives and AI-enabled tools in document creation and review to improve efficiency.
- Knowledge of document management systems, workflows, and process optimization.
- Excellent oral and written communication skills with a keen eye for detail.
- Strong leadership and project management skills, including influencing, negotiating, and problem-solving.
- Demonstrated learning agility and ability to adapt to evolving technologies and regulatory landscapes.
- Ability to work effectively in a team environment and build productive cross-functional relationships.
Preferred Skills: - Knowledge of preclinical research, trial operations, and regulatory requirements
- Experience with IACUC regulations, scientific experimental design, and protocol development
- Familiarity with 510(k) documentation and submission processes
- Copy editing, proofreading, and data synthesis skills
- Understanding of SOPs, research ethics, and quality standard
- Experience with coaching, training, and process improvement initiatives
Other Attributes:
- Ability to meet timeline commitments to deliver high quality scientific writing
- Exceptional organizational and time management skills
- Ability to resolve complex problems independently and under supervision
- Strong interpersonal skills with the ability to influence and collaborate effectively
- Commitment to continuous learning and professional development
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