Title: Medical Writer
Job Location: Bangalore
Department: Medical Writing
About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
Role:
Medical Writer
Key Responsibilities:
- Independently develop and finalize clinical and scientific documents for different regulatory submissions such as (but not limited to) Bioanalytical reports, Clinical Study Reports (CSRs), part of Electronic Common Technical Document (eCTD) modules, covering various therapeutic areas, and phases of clinical research
- Collaborates with internal and external clients to support and enable effective communication resulting in operational excellence
- Effectively manages medical writing and review processes to deliver quality projects in agreed timelines
- Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable
- Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings
- Follow any other instructions and perform any other related duties, as assigned by the supervisor.
- Performs literature search/review as necessary to obtain background information for developing scientific content
Educational Qualification:
- Graduate in Life Sciences
- Masters in Life Science
Experience:
10-12 Years
Behavioural Skills:
- Good communication
- Quick learner
- Adapt to change
- Time management
- Professionalism
Technical/functional Skills:
• Ability to comprehend scientific information
• Good understanding of clinical research.
• Knowledge of working on MS word, PPT etc.
• Attend training on environment, health, and safety (EHS) measures imparted company
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.