Medical Writer II (Process Mapping)

Description

Medical Writer II

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

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

What we re looking for
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.