Senior Medical Writer-Only Immediate Joiners

Designation: Senior Medical writer

Experience: 5years+

Job location: Jayanagar(Work from office)- 3 days a week

Roles & Responsibilities

• 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
• Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality
• Engineers, R&D, and Regulatory Affairs
• Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation
• Assist the Team Lead/Manager in the development of schedules to ensure timely delivery
• 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
• 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
• Conduct editing, proofreading, document formatting, and other document completion/approval activities

Education

• Bachelors Degree / Post Graduation in any relevant Life Sciences field. Masters Degree is preferred.

Experience

• Publication experience in scientific journals preferable
• Minimum 5-6 years of experience in Medical Device Regulatory documentation
• 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 and engaging with multiple clients independently
• Experience of working on projects involving all devices classes from various Therapeutic Areas

Technical/Functional 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 on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage
• Effective reviewing skills for review of work done by trainees/junior writers

Non-Technical Skills

• Strong verbal and written communications 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
• Mentoring skills to act as trainer/mentor for junior members of the team

Personal Traits

• Positive Attitude
• Initiative and Commitment
• Detail Oriented
• Team player
• Focused and sincere
• Perseverance

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
• Good stakeholder management.