- Title: Technical Writer
- Code: RCI-11301
- Location: Princeton New Jersey (NJ) 08540
- Posted Date: 02/19/2021
- Duration: 12 Months
Talk to our Recruiter
- Name:Mangesh Kanade
- Email: email@example.com
- Phone: 908-704-8843 ✖ 260
100 % Remote / Work from home
MAIN PURPOSE OF ROLE
- This role is responsible for writing and editing clinical documents including study specific protocols and reports, clinical procedures and SOPs, 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 Abbott 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
- Bachelor`s Degree in Science, Engineering or equivalent technical degree.
Experience/Background (minimum level necessary)
- Clinical research – Minimum 3 yrs
- 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 personal computer 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 is desirable.
- Ability to effectively work on multiple project at the same time and to appropriately prioritize work.