Senior Medical Writer

3 months ago

Bangalore Metropolitan Area, India Celegence Full time

Qualification(s)

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

Experience(s)

  • 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 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.

Soft 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

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

Personal Traits

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

Roles and 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.

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