job title: Medical Writer 2 (Syneos)

Job Responsibilities

• 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 that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.

• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.

• 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, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.

• Performs on-line clinical literature searches, as applicable.

• Working knowledge of drug development process and regulatory guidelines.

• 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 administrated tasks within the specified timeframes.

• Performs other work-related duties as assigned.

• Minimal travel may be required (less than 25%).

Qualifications

• Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing.

• Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries.

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.

• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.

• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information