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Techinical Writer
Ref No.: 18-01489
Location: West Chester, Pennsylvania
Position Type:Direct Placement
Start Date: 02/12/2018
OVERALL RESPONSIBILITIES:

The Technical Writer, Shared Services acts as a team member supporting and executing the Clinical Evaluation Report and Safety Surveillance Report processes for the assigned therapeutic areas within the MD businesses within his/her scope of responsibility

POSITION DUTIES & RESPONSIBILITIES:

  • Responsible for the writing of Clinical Evaluation Plans
  • Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance to local procedures, the client's guidelines and regulatory requirements
  • Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, the client's guidelines and regulatory requirements
  • Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners
  • Assists in the development of schedules to ensure operating company CER/SSR timelines are met
  • Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
  • Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports.
  • Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process

EDUCATION & EXPERIENCE REQUIREMENTS:

  • BA, BS, or BSN is required; advanced degree is preferred
  • A minimum of 3 years of related job experience is required for this position
  • Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
  • Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods is preferred
  • Regulatory/Notified Body audit experience is preferred