23 Oct
CELEGENCE
Vijayawada
Qualification(s)
- Bachelor’s Degree/Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred.
Experience(s)
- Publication experience in scientific journals preferable
- Minimum 3 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 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.
Soft 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
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
Personal Traits
- Positive Attitude, Initiative and Commitment, Detail Oriented, Team player, Focused and sincere, Ownership and accountability of work.
Roles and 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.
▶️ Senior Medical Writer
🖊️ CELEGENCE
📍 Vijayawada