Job Description

JOB DESCRIPTION

Designation: Senior Executive - Medical Writer
Job Location: Bangalore
Department: Clinical Development

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.

Job Purpose: To help in preparation of clinical trial related documents like synopsis, protocol, Risk Evaluation and Mitigation Strategies (REMS), Informed Consent Document (ICD), Clinical Study Report (CSR), Common Technical Document (CTD), electronic CTD (eCTD) modules and any other document as needed for regulatory submission/requested by sponsor

Key Responsibilities:

• Independently develop and finalize clinical and scientific documents such as (but not limited to) synopses, protocols, investigator brochures, Clinical Study Reports (CSRs), Informed Consent Documents (ICDs), relevant regulatory documents and clinical documents, Electronic Common Technical Document (eCTD) modules, etc. covering various therapeutic areas and all phases of clinical research
• Performs literature search/review as necessary to obtain background information for developing scientific content
• 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.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Educational Qualification:

• Graduate in Life Sciences
• Masters in Life Science

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

Experience:

• At least 3 years of relevant Medical Writing experience

Behavioral Skills:

• Good communication
• Quick learner
• Adapt to changes
• Time management
• Professionalism

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.

Syngene International