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Sr Clin Eval Med Writer - Exempt

Lancesoft

Mounds View, MN

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JOB DETAILS
SALARY
$50
SKILLS
Analysis Skills, Cardiac Monitoring, Clinical Assessment, Clinical Best Practices, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Coaching, Cross-Functional, Data Analysis, Document Management, Documentation Format, Editing, Healthcare Quality, Mentoring, People Management, Policy Development, Procedure Development, Process Improvement, Product Safety, Product Testing, Project/Program Management, Proofreading, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Schedule Development, Strategic Planning, Team Player, Time Management, Writing Skills
LOCATION
Mounds View, MN
POSTED
8 days ago

Join our team in Mounds View, MN, a vibrant location that offers a great work-life balance and a collaborative work environment. We are seeking a skilled professional to take on a pivotal role in our clinical evaluation team.
Key Responsibilities
  • Analyze and integrate diverse clinical evidence to evaluate product safety and performance, identifying potential data gaps or risks.
  • Lead and support clinical evaluations in compliance with applicable global regulatory requirements.
  • Collaborate with cross-functional stakeholders to define clinical evaluation strategies and support regulatory interactions.
  • Maintain current knowledge of clinical evaluation best practices and the evolving clinical and regulatory landscape.
  • Produce clear, accurate, and high-quality clinical documentation.
  • Support risk/benefit and state-of-the-art assessments, manage document timelines, address regulatory feedback, and provide guidance or mentoring to colleagues as needed.
Qualifications
  • Bachelor’s degree with a minimum of 4 years of experience in clinical research/clinical evaluation/clinical evidence, or an advanced degree with a minimum of 2 years of experience in these areas.
  • Experience with clinical evaluation from start to finish is ideal.
  • Experience with cardiac rhythm management devices is highly preferred.
  • Proficiency with literature management tools such as ReadCube is advantageous.
Work Schedule and Location
  • Full-time position: 40 hours per week.
  • Work location: Mounds View, MN.
  • Onsite work required at least 4 days per week.
Additional Responsibilities
  • Identify, compile, and analyze multiple data types to evaluate product safety and performance.
  • Collaborate, plan, and develop clinical evaluations in accordance with relevant guidelines/regulations.
  • Develop and maintain therapeutic and device operation knowledge to produce well-written, clear, and concise reports.
  • Develop search strategies to identify and obtain existing, relevant data.
  • Stay current on the clinical evidence landscape and provide guidance to teams on sufficient data.
  • Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities.
  • Address deficiencies and answer questions from regulatory agencies as needed.
  • Provide guidance, mentoring, and coaching to colleagues.
  • Create and manage project schedules for each document.
  • May lead the development of policies, procedures, and process improvement initiatives for the group or clinical department.

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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