Medical Writer II – Clinical Trial Transparency
Job Description:
- Mentors less experienced medical writers on projects, as necessary
- Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision
- Develops or supports a variety of documents including clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs
- Serves as peer reviewer on internal review team
- Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format
- Adheres to established regulatory standards and completes medical writing projects on-time and on-budget
- Performs on-line clinical literature searches, as applicable
- Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing
- Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership
- Completes required administrative tasks within the specified timeframes
- Performs other work-related duties as assigned
- Minimal travel may be required (less than 25%)
Requirements:
- 1 to 3 years of experience in Disclosure
- Knowledge of Clinical Research, Clinical Trial, clinical registries (CT.gov, CTIS- Clinical Trial information System, EUDRACT)
- Experience in clinical registries, clinical trial Disclosure is mandatory
- Experience in databases like Pharma CM/ Disclose
- Good understanding of protocol registration process
- Fine with combination of redaction Disclosure
- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
- Client interaction experience
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture
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