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 Bachelors Degree / Post Graduation in any relevant Life Sciences field. Masters 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

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 Bachelors Degree / Post Graduation in any relevant Life Sciences field. Masters 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

Designation : CMC writer(Author) Job location: Jayanagar(Bangalore) Work mode: Hybrid(3 days a week) Role & responsibilities 3-7 years of prior CMC Authoring/Writing experience preferred. Hands on in Authoring of the documents . Expertise in Dosage forms and OTC products. Expertise in Formulations. Interested in expanding his/her knowledge of pharmaceutical manufacturing and testing as it pertains to eCTD Modules 2 and 3 writing and support labelling activities Experience in the pharmaceutical or CRO industry preferred Experience in pharmaceutical manufacturing or testing activities is mandatory. You need to be expert in Gap Analysis of the documents Work on the preparation of the documents Independently handle all the collection of the documents Management of the regulatory documents Types of Products and Geographies You will be working on different types of dosage forms, solid orals and some sort of injectables. It is both for New Product development and lifecycle management. You will get a chance to work on various global countries like EU, Europe, LATAM and limited extend to Asia pacific/US FDA. Technical Skills Good Chemistry Manufacturing & Control (CMC)writing skills and understanding of ICH requirements Proficiency with MS Office applications and style guides for writing various document types Ability to convert technical information into regulatory-compliant documentation Soft Skills Excellent English written and verbal communication skills Good organizational, interpersonal and communication skills **We would require someone who can join in 30 days OR an immediate joiner.