Are you a skilled medical writer with a passion for clinical evaluation and regulatory documentation? Meril is currently hiring for the position of Senior Medical Writer at their facility in Vapi. This is an exciting opportunity for professionals with 1 to 5 years of experience in medical writing, particularly in Clinical Evaluation Reports (CERs).
Job Description
As a Senior Medical Writer at Meril, you will play a pivotal role in developing and writing Clinical Evaluation Reports (CERs) for both pre-market and post-market medical devices. Your responsibilities will include ensuring consistency with regulations, quality standards, and organizational goals. Below are the key duties for this role:
Key Responsibilities
- Writing Clinical Evaluation Reports (CERs): Develop coherent and convincing CERs by organizing and evaluating extensive scientific, clinical, and medical data.
- Data Analysis: Plan, identify, appraise, and analyze clinical data, then write comprehensive CERs with well-founded conclusions based on expert knowledge.
- Quality Assurance: Adhere to internal and external Standard Operating Procedures (SOPs), work instructions, and templates for preparing robust CERs and other documents.
- Support Other Projects: Assist with various clinical, regulatory, quality, and engineering projects as assigned.
- Clinical Data Management: Acquire, interpret, analyze, and draw meaningful conclusions from clinical trial data, literature, and user experiences for diverse medical devices.
- Scientific Communication: Clearly and concisely communicate scientific content to stakeholders.
Job Requirements
Educational Qualifications
- Bachelor’s, Master’s, or Ph.D. (preferred) in a scientific discipline.
Professional Experience
- Minimum of 3 years of CER writing experience with a strong understanding of Med Dev 2.7/1, Rev 4.
- At least 3 years of experience in clinical, regulatory, quality, or engineering roles.
Skills and Competencies
- Focused, efficient, and detail-oriented with the ability to work independently.
- Proficient in reading, analyzing, and implementing regulations, standards, and guidance.
- Strong project management skills, including multitasking, prioritizing, and ensuring quality deliverables.
- Exceptional written and oral communication skills.
- Advanced computer skills with Microsoft Word, Excel, PowerPoint, and other tools.
- Proven ability to collaborate with teams, including corporate executives, research sites, and research subjects.
Benefits of Joining Meril
Meril offers a dynamic work environment where you can enhance your skills, broaden your professional network, and contribute to cutting-edge projects in the medical devices industry. Key benefits include:
- Fresh perspectives and innovative problem-solving.
- Opportunities to enhance expertise and productivity.
- An inclusive culture fostering diversity and knowledge transfer.
