Our client is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide.
Technical Writer - Long term contract - work remotely
They are looking for top Technical Writers to work with Shared Services. They will act 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, company guidelines and regulatory requirements
- Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, company 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