Executive-Medical Device Technical Writing Consultant

Executive-Medical Device Technical Writing Consultant

United States

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....

ClinChoice is searching for a Executive-Medical Device Technical Writing Consultant tojoin one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

• Plan and execute general technical writing activities with minimal or no support or guidance and support senior members with project and management activities.
• Ensure assigned technical writing documents (including but not limited to, Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Summary of Safety and Clinical Performance (SSCP) and State of the Art (SOA) are compliant with client procedures, regulatory requirements, and client guidelines
• Ensure efficient management of timeline and aim to increase productivity
• Familiar with industry standards, clinical practice guidelines, safety reporting, and MDR regulations/specifications.
• Ensure documents are compliant with client procedures, regulatory requirements, and client guidelines
• Ensure error-free and acceptable quality in assigned deliverables.
• Alert and escalate to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule.
• Contribute towards the achievement of Quality Objectives.
• Responsible for end-to-end ownership of the document
• Responsible for ensuring training compliance and timesheet compliance.

Education and Experience:

• Thorough understanding of regulatory documents such as MEDDEV 2.7/1 Rev 4, MDR regulations and associated regulatory guidelines.
• Excellent written and verbal communication skills.
• Attention to detail and ability to multitask.
• Possesses logical, analytical and verbal skills
• Bachelor’s Degree in Life Sciences or above and in alignment with project/business team requirements.
• Minimum of 2 to 4 years of relevant experience in identified functional domain/ business work stream

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

We recognize this is our strength and celebrate it.

Key words: Medical Writing, Medical Device, MDD, MDR Regulations

#LIPB1