job title: Sr Medical Writer(syneos)

Job Responsibilities

- Mentors and leads less experienced medical writers on complex projects, as necessary.

- Acts as lead for assigned writing projects.

- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:

- Clinical study protocols and clinical protocol amendments;

- Clinical study reports;

- Patient narratives;

- Clinical development plans;

- IND submissions and annual reports;

- Integrated summary reports;

- NDA and (e)CTD submissions;

- Investigator brochures, as well as;

- Clinical journal manuscripts, clinical journal abstracts, and client presentations.

- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.

- 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 providing review commentson draft and final documents.

- 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.

- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

- Maintains awareness 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%)

-Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT)
-Redaction of protocol and SAP (Statistical Analysis Plan)

Qualifications

- Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT)

-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.