Scientist Medical Writing

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Role Summary

The Medical 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.

Primary Responsibilities

• Responsible for the writing of Clinical Evaluation Plans.

• Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance with local procedures, client guidelines and regulatory requirements.

• Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, client 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

Candidate Profile

• Graduate or Post-graduate in Life Sciences with a minimum of 3 years of experience in Medical, Technical or Scientific Writing.

• 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.