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