Employment Type:

Full time

Shift:

Day Shift

Description:

Holy Cross Hospital in Fort Lauderdale, Florida is a full-service, non-profit Catholic hospital, sponsored by the Sisters of Mercy and a member of Catholic Health East. Since we opened our doors in 1955, the name Holy Cross remains synonymous with medical excellence and highly personalized care with sincere human compassion and understanding.
While spirituality plays an essential role in the way that we minister to our patients, we also maintain state-of-the-art technology, a highly acclaimed medical staff and a variety of innovative services to provide healthcare for the entire family.
Holy Cross is accredited by the Joint Commission and is the first hospital in Broward County to be designated a Magnet Hospital by the American Nurses Credentialing Center. Our many accolades include the 2008 and 2009 U.S. News & World Report "Best Hospital" ranking for Orthopedics and the 2009 American Heart Association/American Stroke Association's Get with The Guidelines Stroke Gold Plus Performance Achievement Award.
Holy Cross Hospital is seeking the ideal candidate looking to get into medical school but needs more experience in field of cardiovascular research. This individual will assist with creation and maintenance of heart failure database, serve as a medical writer, content coordinator for investigator initiated heart failure clinical studies.. while serving as primary technical contact with the internal team.
This is a 1-2 year, FT position on day shift with benefits. Please visit our Career Center Home Page for more about our benefits.

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;

Clinical registries

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 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%).

Assists with enrollment in ongoing clinical research studies

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.