Senior Medical Writer

2 days ago

Delhi, 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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