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Job type: Permanent

Discipline: Clinical Evaluation

Location: United States

Proclinical is currently recruiting for a Clinical Technical Writer with a pharmaceutical company located in Philadelphia, PA.

Job 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, 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.

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