Job Description

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

Bengaluru, India Full Time, On-Site Reporting to Chief Delivery Officer

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.



Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

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

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

Experience

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/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