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Technical Writer in Medical Operations
Ref No.: 17-00510
Location: Raynham, New Jersey
Position Type:Full Time/Contract
Start Date: 01/17/2017
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

Job Location: You are ideally located close to one of the following offices: (Work from home is allowed, after an induction period of 3 months at the client's office)
  • Raynham, MA
  • Warsaw, IN
  • West Chester, PA
  • Client - OH & NJ
  • BWI - CA
Many Thanks
Rohit Ahlawat
Technical Recruiter
Integrated Resources Inc.
IT   REHAB   CLINICAL   NURSING
Inc. 5000 – 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Direct: 732-429-1632
Tel: 732-549-2030  Extn. 228
Fax: 732-549-5549
Mailto: rohit@irionline.com
Website: www.irionline.com
INTEGRATED RESOURCES, INC  WINS INAVERO’S 2016 BEST OF STAFFING® CLIENT AND TALENT AWARDS
https://www.bestofstaffing.com/agencies/integrated-resources-inc/