- This role is responsible for writing and editing clinical documents including study specific protocols and reports, clinical procedures and SOPs, and CAPA documents.
- Works with cross-functional teams to achieve alignment on documentation deliverables.
- Delivers high-quality documentation that is compliant with the Quality System.
- Writes of study-specific clinical protocols and reports.
- Responsible for engaging appropriate subject matter experts and gaining cross-functional alignment on content of documents.
- Verifies and assesses the accuracy, consistency and completeness of data and information in reports and documentation.
- Able to identify and access the sources of information needed to resolve issues.
- Writes or oversees writing of clinical processes, procedures, SOPs, forms, CAPA documents, and other documentation as required.
- Responsible for maintaining consistency across clinical documentation; writing and maintaining a glossary, style guide, and templates, as appropriate, for use by other team members.
- Maintains documents for clinical processes and procedures and ensuring compliance with GCP, regulations, Quality System procedures, and company corporate policies.
- Identifies process improvements in the management and writing of clinical documents.
- Supports and helps draft scientific publications arising from clinical studies, as required.
- Defines and/or conducts formal literature searches to support clinical or other business activities. Summarizes scientific publications clearly and concisely, as required.
- The output provided by this role is subject to external audit (e.g., FDA, ISO). The lack of accuracy, compliance, and timeliness will impact the Quality system at site and division levels.
- Ensures close communication and working relationship with R&D, regulatory, quality, program management and other functional teams in order to achieve documentation deliverables. Maintains awareness of overall project timelines.
- May provide supervision and mentorship to junior staff.
- Miscellaneous other duties may be required.
- Bachelor’s Degree (± 16 years)
- Science, Medical Technology, or equivalent technical degree.
- an equivalent combination of education and work experience.
- Minimum 3 years relevant experience Clinical Research or in a related area such as Technical Product Development, Quality or Regulatory in a healthcare industry.
- Writing, editing, and managing technical documentation utilized for clinical research, for IVD or medical device regulatory submissions or Quality System documentation, or for the development of new medical products.
- Excellent written and oral communication skills with the ability to produce top quality, error-free and grammatically correct written work.
- In-depth knowledge of software programs including Word and Adobe Pro, in Windows environment.
- Experience writing CAPA documents desirable. Knowledge of division products and Quality systems, system linkages and quality measures are desirable.
- Ability to effectively work on multiple projects at the same time and to appropriately prioritize work.
- IVD Experience Preferred
Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.
In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact firstname.lastname@example.org.
All applicants applying must be legally authorized to work in the country of employment.
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