Job Opportunity: CER Writer – Join Our Growing Medical Writing Team!
Summary: Are you a seasoned CER Writer with a passion for medical devices and regulatory writing? MakroCare is seeking a highly motivated and experienced professional to join our team and contribute to the development of high-quality Clinical Evaluation Reports (CERs) that meet the rigorous standards of EU MDR and other relevant regulations. If you have a strong background in literature reviews, clinical data analysis, and scientific writing, and are looking for an immediate opportunity to make a significant impact, we encourage you to apply!
About MakroCare:
MakroCare is a global clinical research organization (CRO) providing a comprehensive suite of services to pharmaceutical, biotechnology, and medical device companies. We are committed to delivering innovative and effective solutions that accelerate drug development and improve patient outcomes. Our team of experienced professionals is dedicated to upholding the highest standards of quality, integrity, and ethical conduct in all our endeavors.
Job Title: CER Writer
Location: India (Hybrid/Onsite – Depending on project requirements)
Experience Required: 5-7 Years
Industry: Medical Writing / Medical Devices
Join Time: Immediate
Responsibilities:
As a CER Writer at MakroCare, you will play a critical role in the development and maintenance of Clinical Evaluation Reports for medical devices. Your responsibilities will include:
- Developing and Updating CERs: Creating and updating comprehensive CERs in accordance with EU MDR 2017/745, MEDDEV 2.7/1 Rev 4 guidelines, and other applicable regulatory requirements.
- Literature Reviews and Data Analysis: Conducting systematic literature searches, critically appraising scientific literature, and performing thorough clinical data analysis to support CER development.
- Evidence Interpretation: Interpreting clinical evidence, analyzing risk-benefit profiles, and integrating Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) data into CERs.
- Collaboration: Collaborating effectively with regulatory affairs, quality assurance, clinical teams, and other stakeholders to ensure alignment and consistency in medical device documentation.
- Quality Assurance: Ensuring the accuracy, clarity, and regulatory compliance of all CER deliverables through meticulous review and adherence to established writing standards.
- Documentation: Maintaining high scientific and regulatory accuracy by following structured documentation processes and maintaining accurate records of all research and analysis.
- Project Management: Independently managing multiple CER projects simultaneously, meeting deadlines, and prioritizing tasks effectively.
Qualifications:
To be successful in this role, you should possess the following qualifications:
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or a related field.
- Experience: 5-7 years of proven experience in medical device CER writing.
- Regulatory Knowledge: Excellent understanding of EU MDR 2017/745, MEDDEV guidelines, and other relevant regulatory expectations.
- Technical Skills: Strong proficiency in scientific writing, literature searching (e.g., using databases like PubMed, Embase, Cochrane Library), and evidence synthesis.
- Analytical Skills: Ability to critically analyze clinical data, interpret scientific literature, and draw sound conclusions.
- Project Management Skills: Demonstrated ability to manage multiple CER projects independently, meet deadlines, and prioritize tasks effectively.
- Communication Skills: Excellent written and verbal communication skills, with the ability to clearly and concisely convey complex scientific information.
- Preferred: Candidates available for immediate joining will be given preference.
Why Join MakroCare?
- Global Exposure: Opportunity to work with global medical device clients and gain experience with a diverse range of products.
- Professional Growth: Exposure to advanced regulatory, clinical, and scientific documentation practices, with opportunities for continuous learning and professional development.
- Collaborative Environment: Work within a collaborative and supportive team environment where your contributions are valued.
- Competitive Compensation: Competitive salary and benefits package commensurate with experience and expertise.
How to Apply:
If you meet the eligibility criteria and are excited about the opportunity to join our growing medical writing team, please submit your updated CV to [email protected] with the subject line: “Application for CER Writer – Immediate Joiner”. We look forward to hearing from you!