Medical Writer

PUB322144

About this role

About this role

We are hiring a REMOTE, Medical Writer, for our client, a Global Medical Device Company. The Medical Writer will primarily focus and be responsible for review and research of medical and scientific literature in order to author Clinical Evaluation Plans (CEPs), Reports (CERs), and Post-Market Clinical Follow-Up (PMCF) Plans, and maintain and update existing CERs. In addition, the Medical Writer may contribute toward or author other technical documents that support clinical and regulatory efforts of the company.

Responsibilities

• Authors Clinical Evaluation Plans (CEPs) and Reports (CERs) and maintains/updates existing company CERs according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR.• Contributes toward post-market clinical safety and risk management programs as requested.
• Post Market Clinical Follow-up Plans and Reports• Critically appraises scientific literature and writes summaries for articles, products and clinical application of products
• Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.• Manages timelines and communication to ensure deliverables and milestones are met.
• Interacts with internal and international teams (engineering/marketing/regulatory) to define the plan and strategy for development of the Clinical Evaluation Reports for new products requiring CE Mark.• Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
• Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.• Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).

Requirements

Requirements

Requirements

• Minimum of Bachelor’s Degree or equivalent in scientific or medical discipline; Master’s Degree preferred• Minimum of 3 years of experience in clinical evaluation report and PMCF writing in the medical device industry.
• Knowledge of software as a medical device is a plus• Knowledge and experience with Medical Devices Directive 93 / 42 /EEC
• Knowledge and experience with MEDDEV 2.7.1 Rev 4 Clinical Evaluations• Knowledge and experience with MEDDEV 2.12-2 PMCF
• Knowledge and experience with EN ISO 14155 Clinical Investigations• Knowledge and experience with ISO14971 Risk Management
• Experience and skill performing medical literature searches (PubMed, Google Scholar, etc.)• Excellent written communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy
• Ability to identify critical information needs and identify roles/individuals to involve for decision making within clinical evaluation assessment and report development• Basic project/timeline management skills and organizational skills
• Ability to prioritize and manage multiple projects• Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures
• Strong familiarity with Microsoft Office• Experience as a medical professional preferred, preferably in critical care settings

Benefits

Benefits

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Join the Brunel Family

Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Meagan Geris is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB322144

Account manager

Meagan Geris
Brunel USA - Houston
m.geris@brunel.net

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