Senior Medical Writer
Year Nungambakkam, Chennai, Tamil Nadu, India
Job Description
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Job descriptionIndustry: Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific CommunicationsPosition: Full Time, PermanentDivision : Pubrica BrandReports to : Pubrica Business HeadWork Schedule:Full Time, Monday to Saturday, 10:00a.m. to 7:00pm. Hours may vary on occasion, depending on workload. Second Saturday Holiday.Work LocationChennai, Tamil Nadu.Req. Qualification:Bachelors degree in Life SciencesPhD, PharmD, or other post-graduate degree.About CompanyGuires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot Manufacturing, Education, Consulting and outsourcing. Under our diverse brand portfolio, we are dedicated to facilitating the development of innovative products and solutions across diverse industries."We are currently seeking a highly skilled and experienced Senior Medical Writer to join our team. The Senior Medical Writer will play a key role in developing and producing high-quality medical content for various projects, including clinical research documents, regulatory submissions, medical publications, educational materials, client communications, thesis, publications, and data extraction.Responsibilities:
- Lead the development of medical writing deliverables, including clinical study protocols, clinical study reports (CSRs), investigator brochures, patient narratives, regulatory submissions (IND, NDA, BLA), scientific publications, client communications, thesis, publications, and data extraction.
- Collaborate with cross-functional teams, including clinical research, regulatory affairs, pharmacovigilance, and biostatistics, to ensure accurate and timely completion of medical writing projects.
- Provide strategic input and guidance on medical writing projects, including study design, data interpretation, regulatory compliance, client communication, on-time dispatch, thesis, publications, and data extraction.
- Conduct literature reviews and research to support the development of medical content and ensure accuracy and scientific rigor, including data extraction for thesis and publications.
- Interpret and summarize clinical trial data, including statistical analyses and results, for inclusion in medical writing documents, thesis, publications, and data extraction.
- Ensure compliance with relevant regulatory guidelines, including ICH-GCP, FDA, and EMA guidelines, as well as company SOPs and standards.
- Review and edit medical writing deliverables for clarity, accuracy, and consistency, ensuring adherence to company and industry standards.
- Mentor and train junior medical writers, providing guidance on best practices, writing techniques, regulatory requirements, client communication, on-time dispatch, thesis, publications, and data extraction.
- Stay abreast of emerging trends, developments, and regulatory requirements in the medical writing field, including those relevant to thesis, publications, and data extraction.
- Advanced degree in life sciences, pharmacy, or related field (PhD, MD, PharmD, Chemistry , or equivalent).
- Minimum of 1+ years of experience in medical writing within the pharmaceutical, biotechnology, Chemistry or contract research organization (CRO) industry.
- Proven track record of writing and editing clinical research documents, regulatory submissions, medical publications, client communications, thesis, publications, and data extraction.
- Strong understanding of clinical research methodologies, biostatistics, and regulatory requirements.
- Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and effectively.
- Proficiency in Microsoft Office Suite and document management systems.
- Ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
- Strong attention to detail and commitment to quality and accuracy.
- Experience with submission-ready document preparation and electronic document management systems (e.g., eCTD).
- Provident Fund
- Day shift
- Performance bonus
- Quarterly bonus
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Job Detail
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Job IdJD3340459
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationNungambakkam, Chennai, Tamil Nadu, India
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EducationNot mentioned
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ExperienceYear