• Bachelor’s Degree / Post Graduation in any relevant Life Sciences field.
• Master’s Degree is preferred.
Experience
• Minimum 2 years of experience in Medical Device Regulatory documentation.
• Publication experience in scientific journals is preferable.
• Familiarity with the Life Sciences Industry, preferably Regulatory Services.
• Hands-on experience on CEP/CER/PMSR/PSUR process.
• Experience in creating high-quality deliverables for customers.
• Experience in handling projects independently with minimal guidance.
Technical Skills
• Knowledge of clinical evaluation and related documents and regulatory requirements.
• Proficiency in comprehension of scientific data and medical terminology, and efficiency in summarizing information from source documents and published literature.
• Proficiency with Microsoft Office (Word, Excel, and Outlook).
• Hands-on experience with presentation tools (PowerPoint, Visio, etc.) and referencing tools (Zotero, Endnote, etc.) is an added advantage.
• Effective reviewing skills for review of work done by trainees/junior writers.
Soft Skills / Non-Technical Skills
• Strong verbal and written communication skills.
• Ability to work as part of a team.
• A constant zeal towards learning and skill development.
• Potential to multitask and work within timelines.
• Ability to understand and deliver on customer requirements.
• Potential leadership and mentoring skills.
Competencies
• Basic English grammar, punctuation, and sentence construction.
• Logical comprehension.
• Knowledge of medical terminology.
• Excellent Communication (Writing and Verbal).
• Quality-focused mindset.
• Positive time management.
Personal Traits
• Positive Attitude.
• Initiative and Commitment.
• Detail-Oriented.
• Team player.
• Focused and sincere.
• Ownership and accountability of work.
Roles & Responsibilities
• Perform literature searches on various databases.
• Screening, appraisal per pre-defined criteria, and summarization of articl