Clinical Technical Writer
Proclinical is currently recruiting for a Clinical Technical Writer with a pharmaceutical company located in Philadelphia, PA.
- 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
- Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports.
Skills and 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
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.