Medical writer 2 (syneos)

Roles and Responsibilities

Job Responsibilities

• 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 candidate with combination of redaction Disclosure.

• 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:

• 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

• Experience writing relevant document types required

• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Necessary Skills:

• Strong presentation, proofreading, collaborative, and interpersonal skills

• Strong project and time management skills

• Strong proficiency in MS Office

• Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information