Medical Writer: Cardiovascular Research Foundation

Who we are:

The Cardiovascular Research Foundation, headquartered in New York City , has been dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine for over fifteen years.

By establishing the safe use of new technologies and pharmacologic agents, CRF has played a major role in the remarkable advances in survival and quality of life being realized for patients with cardiovascular disease.

Become a part of our team and help CRF serve as a major catalyst in the field of interventional vascular medicine.

Medical Writer

Job Description:

The Medical Writer will focus on the primary responsibility of crafting, writing, reviewing and finalizing trial related documents and submissions to the Regulatory Agencies (RAs). The Medical Writer will also develop strong relationships with key opinion leaders (KOLs), local thought leaders, key academic institutions and researchers to further the Cardiovascular Research Foundation (CRF) presence in the publication community.

Responsibilities include:

· Works with physicians, investigators, medical directors, statisticians and clinical trial team members to develop protocols; clinical study reports, efficacy summaries; safety summaries; investigational drug brochures, sections for IND/IDE applications; clinical sections of regulatory submissions, manuscripts, external and internal presentations.

· Assists with the development of the informed consent, manual of operation prototypes in conjunction with the clinical trial team.

· Reviews data listings and writes table analyses.

· Preparation of documentation for medical communications programs (e.g. website stories, abstracts, manuscripts) in collaboration with media and publications teams.

· Provides project management of writing-only projects.

· Researches and summarizes relevant literature references.

· Acts as collaborative team member to support the development, authoring, review, and completion of high quality documents for regulatory submission.

· Prepares for technical discussions to advance the messaging or technical interpretation of material for clinical study reports, investigator brochures or other documents.

· Reviews draft tables, listings and graphs for content, completeness and presentation.

· Prepares and edits document formatting; organizes, collates and distributes final documents.

· May mentor and train junior staff.

· Provides technical direction and oversight for authored documents.

· May participate in publication activities team or product review board.

· Implements and monitors adherence to standards, processes, and procedures.

· Maintains and communicates knowledge of current professional, technological, and regulatory developments in medical writing.

· Ensures all documents are well-organized, accurate, consistent, and in compliance with applicable company SOPs and regulations.

· Ensures that all projects are completed in a timely manner and within budget, performing additional duties as required.

· Other duties, as required.

Job Requirements:

· Prefer MD, PhD or MS in relevant scientific discipline is preferred; BS or equivalent required. A minimum of 2 to 3 years medical writing experience within the pharmaceutical/biotech industry is required.

· Must have a basic understanding of medical terminology and statistical methods.

· Knowledge and application of the US and European Union (EU) requirements and guidelines, including International Congress on Harmonization (ICH).

· Solid understanding and experience with application of Good Clinical Practices (GCP).

· Some experience training and/or managing staff or delegating assignments to medical writing associates.

· Established mastery in writing and review of protocols, clinical study reports, statistical outputs such as tables and listings, investigator brochures, and other clinical summary documentation for regulatory submissions.

· Excellent computer skills, including word processing and graphic presentations. Excellent verbal and written communication, organizational, and time management skills.

· A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments.

· Demonstrated understanding of the device/drug discovery/development process in the pharmaceutical/biotech industry. Ability to present scientific/clinical information to scientific and non-scientific audiences.

· Proficient with Microsoft Outlook, Word, and Excel. Basic understanding of database programs such as Access is extremely helpful.

· Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike. Mastery of English language (spoken and written). Ability to verbally communicate effectively with data management, department clinical research and other team members.

· Ability to multi-task and interface with users who are working under deadlines. Ability to set priorities and excellent organizational planning, project management and time management skills.

Benefits:

· Choice of health plans that include medical, dental and vision coverage.

· Company-paid short-term and long-term disability and life insurance.

· Health and dependent care flexible spending accounts.

· Pre-tax travel expenses through TransitChek program.

· 401(k) plan.

· Generous paid time off (PTO) entitlement CRF employees accrue four weeks of PTO in first year of employment; five weeks of PTO in the second through fourth years.

· Ten paid holidays each year.

· Discounted health club membership.

Contact Information:

To be considered for this opportunity, please submit your resume, including salary requirements and availability to the Recruiter-fax (212) 851-9280 or email to job@crf.org. Please refer to job title "Medical Writer" in your cover letter.

Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org

CRF is an equal opportunity employer.