Senior Medical Information Scientist

Fresenius Medical Care North America • Charlotte, NC • 8h ago

PURPOSE AND SCOPE:

Support FME's mission, vision, core values, and customer service philosophy. Adhere to the FMCNA Compliance Program, including following all regulatory and company policy requirements.

Drive the success of the Medical Information & Communication group (MIC) within the RTG Medical Department. Ensure compliance of all Medical Information & Communication (MIC) materials with medical best practices and internal and external regulations and guidance.

Provide excellence in medical information to ensure optimal use of FME products

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Provide excellence in medical writing of medical information and educational materials

Develop non-product related clear and concise scientific presentations and manuscripts on disease state and best treatment practices

Regularly update the existing library of educational materials based on current published evidence and proven clinical best practices in the field of nephrology and dialysis

Apply scientific expertise in daily self-dependent professional medical writing and in-depth literature searches

Keep up-to-date with and provide expertise on current applicable FME and FDA legal and compliance guidance

Ensure and document compliance of medical information and educational materials for internal and external auditing

Ensure all current materials are approved in the FME document management system (Windchill)

Other duties as assigned.

Assist with various projects as assigned by a direct supervisor.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

Perform duties typically associated with working in an office environment (i.e., sitting, typing, and light lifting). Reasonable accommodations may be made for individuals with disabilities to perform the essential functions. Ability to invest time, as required to expediting or completing assignments that may necessitate working evening and/or weekend hours as necessary to meet business demands. Some domestic travel required up to 10% of the time.

EDUCATION:

Minimum of a Master of Science degree in an allied healthcare field with a strong background in academic medical and scientific research

PharmD., Ph.D. or MD strongly preferred

EXPERIENCE AND REQUIRED SKILLS:

5 - 8 years' related experience; or a Master's degree with 3 years' experience; or a PhD without experience; or equivalent directly related work experience.

Documented strong expertise in literature evaluation, data analysis and self-dependent professional medical writing is required.

Preferably, the candidate will have publications in relevant journals and experience in presenting at medical or scientific symposia and congresses.

Expertise in Nephrology and Dialysis strongly preferred

Good understanding of the pharmaceutical industry and health care environment and its regulations

Excellent proficiency and experience in medical and scientific literature identification and evaluation

Excellent medical writing and editorial skills, validated by past work experience.

Ability to present papers and communications in the professional medical environment.

Organizational and time management skills

Ability to handle frequent interruptions, changing priorities and multiple projects with tight deadlines

Team orientation and collaboration paired with independent and sound judgment

Familiarity with PC-based applications, including Microsoft Word, Excel and PowerPoint

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

EOE, disability/veterans

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