Global Opportunities to Join the Celegence Team At Celegence, you have the opportunity to shine and truly make a difference. We have a growing organization where your inputs will be valued. We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds. Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment. Celegence is an Equal Employment Opportunity Employer All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment. Why work at Celegence? Be a part of a remarkable journey! Collaborative Team Here at Celegence, you get a great team that always stands by you. Supportive Manager A supportive Manager who makes sure you are absolutely comfortable with the work you’re doing. HR team An amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then). Leadership Team Here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.

Senior Medical Writer

- Bangalore
- Hybrid
- Reporting to Manager, Medical Device Services

Qualifications

- Bachelor’s Degree / Post Graduation in any relevant Life Sciences field.
- Master’s Degree is preferred.

Experience





- Minimum 5+ 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 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 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.
- 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.
- Valuable stakeholder management.

Personal Traits

- Positive Attitude.
- Initiative and Commitment.
- Detail-Oriented.
- Team player.
- Focused and sincere.
- Ownership and accountability of work.

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.

📌 Senior Medical Writer (Bengaluru)
🏢 CELEGENCE
📍 Bengaluru