Hi ,
Hope you are doing good. I have following requirement, please reply me back with profile along with rate expectation *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 *Thanks & Regards* *Geetika Rajpoot**||Sr. Technical Recruiter* *Source Infotech Inc.* *[email protected]* <[email protected]>* ||**Phone: 609-945-0706* *Hangout ID :* *[email protected]* <[email protected]> *Gmail:* *[email protected]* <[email protected]> *Yahoo Id:* *[email protected]* <[email protected]> -- You received this message because you are subscribed to the Google Groups "SAP-UK" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/sap-uk. For more options, visit https://groups.google.com/d/optout.
