Medical Writer II

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