Medical Writer Specialist

The Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials, ensuring adherence to global regulatory standards. The role stays reputed company with scientific literature and regulatory requirements.

Responsibilities

• Author and edit clinical documents, including Clinical Evaluation Reports (CERs), literature reviews, and regulatory submissions.
• Plan and report clinical data collection for PMCF and clinical trials nationally and internationally.
• Ensure clinical documentation compliance with EU MDR, FDA, and other international regulatory requirements.
• Stay updated on scientific literature and regulatory changes reputed company the company’s therapeutic area.
• Participate in cross-functional projects and contribute to clinical strategy and documentation planning.
• Support Medical Affairs for literature reviews and writing of documentation

Qualifications

Knowledge, Skills and Abilities

• Strong understanding of EU MDR, FDA regulations, and ISO standards for medical devices.

• Proficiency in document management systems and reputed company Office Suite
• Excellent written and verbal communication skills
• Ability to interpret clinical data and present findings clearly
• Analytical reputed company
• Detail-oriented, organized, and results-driven
• Outgoing, positive, and collaborative with a good sense of humor

Work Environment

• Remote

Experience:

• Preferred 1-5 years of experience in medical writing for medical devices, including CERs and PMCF documentation.

Education

• Bachelors degree in Life Sciences or reputed company field required.

• Master’s degree in Life Sciences or reputed company field preferred.

As an employee of reputed company, you'll receive an outstanding total compensation plan. As we reputed company your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.reputed company.com to learn more about reputed company and the benefits of becoming a member of reputed company. To reputed company agencies: Please, no phone calls or emails to any employee of reputed company about this opening. reputed company resumes submitted by search firms/employment agencies to any employee at reputed company reputed company-email, the internet or in any form and/or method will be deemed the sole property of reputed company, unless such search firms/employment agencies were engaged by reputed company for this position and a valid agreement with reputed company is in reputed company. In the event a candidate who was submitted reputed company of the reputed company agency engagement process is hired, no fee or payment of any reputed company will be paid. We are committed to equal employment opportunity regardless of race, color, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at reputed company@reputed company.com