Technical Writer/ Medical

Troy - Michigan - United States - Life Sciences & Health Care - Pharmaceutical - Research & Development - Professional Bachelor

Job Title:Technical Writer in Medical Operations;

Department:Medical Operations.

Feel free to contact

Arpita Sharma, Account manager

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About this role

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 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;
  • 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 timeline is met;
  • Participates in workshops and on initiatives to help define processes globally and keep;
  • abreast of CER regulatory requirements and industry trends/practices;
  • 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.

Summary

  • Vacancy number: PUB203229
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Professional Bachelor
  • Area of Expertise: Research & Development
  • Closing date: Thursday, February 20, 2020
Apply now

Feel free to contact

AS

Arpita Sharma

Account manager Brunel Canada Toronto

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