This is open for multiple locations !!
Title: Clinical Technical Writer
Locations: Onsite for 3 months and then ALL REMOTE
Raynham, MA
Warsaw, IN
West Chester, PA
Ethicon-OH & NJ
BWI- CA
Duration: 24 months
Interview: Assessment Test, Phone Interviews
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
· 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
Ashutosh Tripathi-
Team Lead - Recruitment
Ph- 609-608-0442 || Fax: 732-909-2282
Email: atripathi@sourceinfotech.com
Connect: www.linkedin.com/pub/ashutosh-tripathi/49/1a9/2b0
Hangout: ashutoshtripathi68 Yahoo# ashu_recruiter
http://www.sourceinfotech.com/
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