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3.5

based on 22 Reviews

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2 Celegence Systems Jobs

Senior Medical Writer

3-8 years

₹ 8 - 14L/yr (AmbitionBox estimate)

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This is an estimate of the average salary range for this position. It has not been reviewed by the company, and the actual salary may differ.

Bangalore / Bengaluru

1 vacancy

Senior Medical Writer

Celegence Systems

posted 12hr ago

Job Description


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

Employment Type: Full Time, Permanent

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What people at Celegence Systems are saying

3.0
 Rating based on 1 Senior Medical Writer review

Likes

Learning and growth Opportunities to work on different projects

  • Skill development - Good
  • +1 more
Dislikes

Work life balance Salary and hikes

Read 1 Senior Medical Writer review

Senior Medical Writer salary at Celegence Systems

reported by 15 employees with 3-10 years exp.
₹8 L/yr - ₹14 L/yr
6% more than the average Senior Medical Writer Salary in India
View more details

What Celegence Systems employees are saying about work life

based on 22 employees
60%
86%
61%
80%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Celegence Systems Benefits

Team Outings
Work From Home
Health Insurance
Free Transport
Child care
Gymnasium +6 more
View more benefits

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