Senior Executive - Medical Writing Job in Syngene International

JOB DESCRIPTION

Designation: Senior Executive Medical Writing

Job Location: Bangalore

Department: Medical and Regulatory Affairs, 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 develop and finalize clinical and scientific documents related to medical writing, with a focus on bioanalytical report writing

Key Responsibilities:

• Independently develops and finalize clinical and scientific documents including bioanalytical report, eCTD modules and scientific communication documents
• 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
• Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable and deliver quality projects in agreed timelines
• Creates and maintains SOPs and work instructions for preparation and maintenance of compliant medical/scientific writing deliverables
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings
• Review of drafts including content review, QC, and editing of drafts and final documents prepared by other/junior team members before sharing with internal and external client
• 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
• Attend training on environment, health, and safety (EHS) measures imparted company.

Educational Qualification:

M.Pharm / M.Sc

Technical/functional Skills:

• Knowledge Bioanalytical procedures and report writing
• Preparation of eCTD document s for regulatory submissions (Microsoft office and Adobe familiarity)
• Good command on English language and grammar

Experience: 1-2 years in report writing (preferably bioanalytical report) for regulatory submission

Behavioral Skills:

• A team player: Actively contributes to the group in order to complete tasks, meet goals.
• Aspire to learn: Have qualities that will help learn the procedures quickly and manage projects
• Amicable: Able to make amicable and yet relevant conversations with cross-functional teams that enable delivery of quality documents within timelines

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.