Employment Type:

Shift:

Description:

This is a FT position on day shift with benefits.

JOB RESPONSIBILITIES

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 comments on 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%).

QUALIFICATION REQUIREMENTS

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.

Our Commitment to Diversity and Inclusion

Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.