Senior Medical Writer

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.