Location: Bengaluru, Karnataka, India
Job Type: Full-Time | Hybrid Work Model
Reporting To: Senior Manager
Experience Required: 5+ Years
Eligibility: Freshers are not eligible for this role
About the Company
Celegence LLC is a globally recognized Regulatory Affairs consulting and technology solutions company headquartered in Chicago, USA, with international offices in the United Kingdom and Bengaluru, India. The organization specializes in delivering end-to-end regulatory compliance solutions, medical writing services, and innovative regulatory technology platforms for the global life sciences industry.
The company supports pharmaceutical, biotechnology, and medical device organizations in navigating complex global regulatory frameworks while improving operational efficiency and patient-centric outcomes.
Job Overview
Celegence LLC is hiring an experienced Senior Medical Writer to support global regulatory documentation, clinical evaluation activities, and scientific content development. The ideal candidate should possess strong expertise in regulatory medical writing, clinical claims assessment, CER strategy, and interpretation of scientific and safety data for medical devices and life sciences projects.
This opportunity is best suited for professionals with prior experience in regulatory submissions, clinical evaluation reports (CERs), and medical documentation aligned with global compliance standards.
Key Responsibilities
Prepare and review high-quality regulatory and scientific documents for global submissions
Develop Clinical Evaluation Reports (CERs), gap assessments, and regulatory documentation
Analyze clinical claims, scientific literature, safety data, and device performance information
Support regulatory strategy development and documentation planning
Address and resolve observations raised by Notified Bodies on technical and clinical documents
Perform literature reviews, data interpretation, and scientific summarization from published sources
Collaborate with cross-functional global regulatory and clinical teams
Mentor junior medical writers and support quality review processes
Ensure compliance with global regulatory guidelines, GSPRs, and documentation standards
Deliver projects within defined timelines while maintaining high-quality standards
Educational Qualifications
Bachelor’s Degree or Postgraduate Degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare disciplines
Master’s Degree preferred
Required Experience
Minimum 5 years of experience in Medical Writing with focus on Regulatory Submissions
Experience in Clinical Evaluation Reports (CERs) and regulatory documentation
Strong understanding of GSPRs, medical device regulations, and clinical evaluation processes
Proven expertise in gap analysis and regulatory compliance documentation
Prior exposure to handling Notified Body queries and observations is highly preferred
Technical Skills Required
Strong understanding of medical terminology, scientific literature review, and clinical data analysis
Knowledge of global regulatory requirements and clinical evaluation standards
Proficiency in Microsoft Office tools including Word, Excel, Outlook, and PowerPoint
Experience with referencing tools such as EndNote, Zotero, or similar platforms
Ability to critically evaluate scientific evidence and summarize complex medical information
Strong reviewing and quality-checking capabilities for junior writers’ work
Soft Skills & Professional Competencies
Excellent written and verbal communication skills
Strong stakeholder management and cross-functional collaboration abilities
Effective multitasking and project management skills
Detail-oriented approach with quality-focused mindset
Strong mentoring and leadership potential
Good logical comprehension and analytical thinking
Ability to work efficiently within strict project timelines
Preferred Personal Attributes
Positive and professional attitude
High level of commitment and accountability
Team-oriented mindset
Strong perseverance and willingness to continuously learn
Focused, sincere, and quality-driven work ethic
Why Join Celegence LLC?
Opportunity to work with a globally expanding Regulatory Affairs organization
Exposure to international medical writing and regulatory projects
Hybrid work flexibility in Bengaluru
Collaborative learning-driven environment with strong career growth opportunities
Work on cutting-edge regulatory technology and compliance solutions for the global healthcare industry
Important Note for Applicants
This is a senior-level opportunity designed for experienced Medical Writing professionals. Candidates with prior exposure to Regulatory Affairs, CER writing, Medical Devices, Clinical Evaluation, or Scientific Documentation will be preferred.
Freshers looking to enter Medical Writing may consider applying for trainee or junior medical writer positions to build foundational industry experience.
Apply Now
Interested candidates can apply through the official careers portal of Celegence LLC or explore more verified global pharmaceutical, clinical research, regulatory affairs, pharmacovigilance, and medical writing jobs on ThePharmaDaily.com.
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