Qualifications
- 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.
- Good 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 articles.
- Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use.
- Summarize quantitative data from post-marketing surveillance.
- Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas.
- Work with senior writers to prepare documents that meet client expectations in terms of language, content, format, and presentation.
- Conduct proofreading, document formatting, incorporate comments from reviewers, and other document completion/approval activities.
- Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
- Train and mentor junior members of the team on technical/process-related aspects.
- Conduct proofreading, editing, document formatting, review comment incorporation, and document completion/approval activities.
