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.
Positive 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 docu

📌 Medical Writer II (Bengaluru)
🏢 CELEGENCE
📍 Bengaluru