Technical Writer

$160K - $180K ($160K - $180K base + Weekly pay and service bonus plans)
Posted on 09/05/17 by Chuck Srinivas
Confidential Company
Orlando, FL
Less than 5 years experience
$160K - $180K
($160K - $180K base + Weekly pay and service bonus plans)
Posted on 09/05/17 Chuck Srinivas

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

Responsible for the writing of Clinical Evaluation Plans

  • Responsible for compliant writing of Clinical EvaluationReports 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


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

Remunaration package and contract form:

This position comes with enhanced benefits which include:

•                          50/50 shared healthcare cost (Company pays 50% of the monthly premium, employee pays 50%)*

•                          Paid holidays

•                          Paid sick days and vacation days*

Specifically: 10 Accrued PTO, 5 sick days, 9 JNJ facility holidays.

you will have access to numerous perks, including:

Exposure to a variety of career opportunities as a result of our expansive network of client companies

Career guides, information and tools to help you successfully position yourself throughout every stage of your career

Access to more than 3,000 online training courses through our Company Learning Center

Weekly pay and service bonus plans*

Group- rate insurance options available immediately upon hire*

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