Full Time Inhouse Medical Writer

3 weeks ago


ahmedabad, India NovoBliss Research®️ Private Limited Full time
Company Description
NovoBliss Research®️ Pvt Ltd is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. The company has a spacious 10,000 sq ft facility dedicated to scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. NovoBliss Research is a specialized CRO, conducting trials in diverse industries including Nutraceuticals, Dietary Supplements, Dermatology, Pharmaceuticals, Cosmetics, and Personal care.
NovoBliss offers exemplary Real World Evidence Studies for Pharmaceuticals, Nutraceuticals, and Cosmetics encompassing retrospective data collection, post-marketing observational studies, epidemiological clinical studies, and prospective interventional clinical studies, all underpinned by robust design, and expert data analysis. With proficiency in claims substantiation studies, NovoBliss ensures compliance with the latest country-specific regulations, navigating the challenges in clinical trials with tailored studies ranging from observational to interventional.
NovoBliss's leadership team boasts a collective experience of over 36 years in national and international clinical research, anchored by Dr. Nayan Patel (General Physician) and Dr. Maheshvari Patel (PhD Pharmacologist). Both are devoted to implementing global standard clinical trials for Herbal, Nutraceuticals, and Ayurvedic products and Dr. Maheshvari Patel's role as an Expert associated with the Advertising Standard Council of India (ASCI) in Dermatology underscores their dedication to ethical advertising standards.
Role Description
This is a full-time in-house Medical Writer role located in Ahmedabad. The Medical Writer will be responsible for performing literature review to gather scientific information, creating protocols, developing manuscripts, and presenting research findings. Additionally, the Medical Writer will be responsible for interpreting and presenting data, and authoring scientific reports, abstracts, presentations and posters.
Qualifications
Scientific Writing, Medical Communications, and Medical Writing skills
Proficiency in Writing and Research
Experience in Medical Communications or Medical Writing
Thorough understanding of clinical trial methodologies and their application to regulated product development
Familiarity with the regulatory guidelines including ICH guidelines, FDA regulations, GCP guidelines
Excellent written and verbal communication skills, as well as the ability to work collaboratively with cross-functional teams
Understanding of the principles of statistics and good data manipulation practices that meet regulatory requirements is desirable
Mater of pharmacy, or Dentist with Clinical research writing experience , Pharm D
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