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Sr Medical Writer
Ref No.: 18-10656
Location: Mounds View, Minnesota
Start Date / End Date: 09/24/2018 to 09/23/2019
Top Skills needed:

-Bilingual Chinese/English
-Medical device or pharmaceutical experience
-Clinical evaluations or regulatory medical writing
-Strong communication

We need to identify a candidate local to sit on site in Minneapolis. Possible contract to hire opportunity.

Responsibilities may include the following and other duties may be assigned. This role is reporting to Michelle Cercioglu in Minneapolis.

• Primarily responsible for writing and maintaining Clinical Evaluation Reports for the CRHF portfolio of products according to Chinese Regulations and applicable guidance documents
• Compiles, analyzes and synthesizes multiple data types (clinical investigation results, literature and clinical experience) in order to evaluate product safety and performance.
• Collaborate (writing, reviewing, editing, approval) with clinical, R&D, quality, and regulatory teams on clinical evaluation reports, clinical impact assessments, post market surveillance reports, and other documents that require the evaluation of clinical data and/or clinical literature.
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
• Develop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written reports.
• Develop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies' guidelines on clinical evaluation requirements.
• Create and manage project schedule for each document
• May provide input and direction to project teams in order to arrive at a sound clinical evaluation.
• Participates in process improvement initiatives


BASIC QUALIFICATIONS:
EDUCATION & JOB EXPERIENCE

• Fluent English (writing/reading/speaking)
• Fluent Chinese (writing/reading/speaking)
• BS or BA (Clinical or Scientific)
• Medical device experience
• Project management experience
• Clinical research or related experience
• Medical writing and/or scientific writing experience within a medical device or related industry

YEARS OF EXPERIENCE
• 7+ Years with a University Degree
• 5+ Years with Masters or Advanced Degre

DESIRED/PREFERRED QUALIFICATIONS
EDUCATION & JOB EXPERIENCE
• Masters or PhD degree(s) in biomedical sciences or technical disciplines
• CRHF therapies/technology experience
• Direct experience with medical and/or scientific writing within a medical device industry or related industry
KNOWLEDGE & SKILLS/COMPETENCIES
• Proficient knowledge of medical terminology, clinical research study processes, basic statistical concepts, demonstrated ability to incorporate and adhere to regulatory standards
• Proficient knowledge of physiology and/or applicable disease states, CRHF therapies and technologies
• Proficient in word processing, spreadsheets, and/or database applications (e.g., MS Word and Excel)
• Possess strong understanding of study design, metrics and medical writing
• Ability to identify critical information needs and identify roles / individuals to involve for decision making
• Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements.
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing
• Demonstrated ability to identify and adapt to shifting priorities and competing demands
• Demonstrated ability to maintain composure in difficult circumstances
• Demonstrated ability to identify and overcome obstacles
• Ability to constructively respond to feedback from customers and coworkers; team player
• High attention to detail and accuracy
• Process improvement capability