Job Description

Overall Summary

Preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs and their supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, and statistical analyses in a clear and accurate manner consistent with the target audience and regulatory requirements.

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At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. To accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. Come and join Team MicroPort!

Why You’ll Love MicroPort

You will find our team atmosphere is warm, challenging and rewarding. In addition to working with a world-class team locally and abroad, receiving a competitive salary, our Costa Rican employees also enjoy the following benefits: Medical Insurance which includes Dental and Vision, Leaves of Absence including Bereavement, Maternity and Paternity Leave, Studies, paid and non-paid additional days; Seniority Days, Paid Holidays, Education Assistance... and more! At MicroPort, we care about our employees.

Your duties will include:

1. Collaborates with clinical operations, regulatory affairs, and other departments as required on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, Investigator’s Brochures, and presentation materials.
2. Write and reference high-quality scientific manuscripts, slide presentations, posters, publications, surveys, brochures, newsletters, market research reports, and educational materials for a managed markets/communications agency.
3. Is responsible for all background preparation, literature searches, table preparation, graph interpretation, and interpretation of all health policies for assigned communications.
4. Support preparation of company core data sheets.
5. Provide a detailed review of regional CERs to ensure accuracy and consistency.
6. Work directly with the affiliates to ensure accurate and timely revisions and updates of required label information.
7. Work closely with the team to ensure projects are managed appropriately and completed according to deadlines, highest quality, and budget specifications. Organize and conduct PMS meetings according to the established meeting schedule.
8. Provide key analysis of product safety by preparing complaint rates and complaint trends reports.
9. Conduct search and review published information and provide summary reports on published clinical data for the MPO and competitive products. Assist in writing initial Clinical Evaluation reports (CERs).
10. Review Device Registries and government databases for MPO and competitive products.
11. Write and distribute summary PMS reports and update the electronic database.
12. Routinely update CERs with new PMS data after each PMS review.
13. Provide training on the Post Market Review procedure and database keeping to new employees.
14. Work closely with the respective departments to identify and analyze trends arising from product complaints, clinical studies, competitive products, literature reviews, etc.
15. Provide input into identifying failure modes and risk assessment for new products under development and review FMEA reports.
16. Analyze, interpret, and disseminate results from clinical studies.
17. Create and update Clinical Evaluation Plans (CEPs), a Summary of Safety and Clinical Performance (SSCP), and periodic safety update reports (PSURs).

Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

About You

We might be a great match if you:

• Must be familiar with basic orthopedic knowledge (i.e. anatomy, diseases of joints, science of joint replacement, etc.) to read and comprehend published scientific literature.
• Must possess strong leadership skills and excellent analytical and problem-solving abilities.
• Good communication skills and technical writing skills are a must.
• With some experience in the medical device industry with a focus on clinical research, quality is preferred.
• Entry level with a strong scientific background and independent research skills will also be considered.
• Must work well within a team environment.
• Must have the ability to balance multiple ongoing projects, timelines, and outputs

YOUR EDUCATION

Bachelor’s Degree in a biomedical, life sciences, or related field.

YOUR EXPERIENCE

Minimum one year required, including a combination of internship and/or research experience.