Medical Writer II – Clinical Trial Transparency

🕒 March 5

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥📝 Medical Writer

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 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