Medical Writer II – Clinical Trial Transparency

Work from home Full-time role Hiring

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%)

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 Apply To this Job