This site uses cookies. To find out more, see our Cookies Policy

Clinical Medical Writer in Orange, California at KaVo Kerr

Date Posted: 12/6/2018

Job Snapshot

Job Description

Job ID: KAV003429

About Us

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community.  KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential.  KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


Description

Job Summary: The Clinical Medical Writer is responsible for performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs), Clinical Evaluation Plans, Post Market Surveillance Plans /Post Market Clinical Follow-up Plans and processes in compliance with MEDDEV 2.7.1 Rev. 4. 

The primary focus will be preparing, writing, editing, and reviewing pre-clinical, clinical and post-market clinical data reports or summaries required for CERs, including a comprehensive literature review, appraisal, and analysis for state of the art, subject device and/ or equivalent devices. He/she provides dental writing expertise for multiple product families and/or projects within the dental area. This job will interface with external groups (e.g. RA, QA, Data management, Marketing to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions and will serve as the scientific writing content expert for the Clinical Affairs group.


Key Responsibilities:
  • Responsible for Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs) for EU MDR compliance and ensure CERs are updated to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR.
  • Work closely with the Regulatory team(s) on document strategies. Implement activities related to the preparation of and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents.
  • Participate in post-market surveillance (PMS) activities as needed (e.g. customer surveys, systematic literature alerts and systematic reviews and preparation of summaries or formal reports for product teams or regulatory agencies.
  • Able to recognize potential scheduling and resource conflicts for projects across the dental area/product assignments and provide recommendations to resolve the issue.
  • Manage the internal CER process in collaboration with the CER team to ensure compliance to relevant SOPs and quality processes, regulations, and expectations of regulatory agencies.
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. 
  • Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
  • Experience and skill performing comprehensive literature searches (PubMed, Google Scholar, EMBASE, etc.), review and interpret the literature.
  • Obtain and analyze current Instructions for Use (IFU) in comparison with current scientific literature and clinical data.

Job Requirements



Qualifications

Requirements:
  • Bachelor's degree in English or Communications required.
  • 2+ years of significant, medical writing experience in any discipline (general medicine, veterinary, dental, etc.) required.
  • Preference will be given to candidates who possess 2 or more years of dental writing experience.
  • A general knowledge or familiarity of GCP, ICH guidelines, FDA regulations and EU regulations.
  • General knowledge of English grammar, punctuation and overall writing skills.
  • Must have good verbal communication skills for working with teams.
  • Excellent computer skills including MS Office (Word, Excel, PowerPoint).
  • Highly organized, self-motivated, and detail-oriented.
  • Proven ability to work independently, meet deadlines, and manage multiple projects simultaneously.

Physical requirements/abilities: 

  • Must be able to sit for several hours. Work may involve repetitive arm/wrist motions.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

#LI-LT1


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.