Senior Scientist-Human Pharmacology Unit
Bangalore, KA, IN, 560100
Job Title: Senior Scientist - Human Pharmacology Unit
Job Location: Syngene International Limited, Bengaluru
About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit
Mandatory expectation for all roles as per Syngene safety guidelines
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene’ s quality standards at all times
- Hold self and their teams accountable for the achievement of safety goals
- Govern and Review safety metrics from time to time
Core Purpose of the Role: Medical Writer
Role Accountabilities:
- 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 with 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
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience
- Demonstrated Capability
- Education
Experience
Looking for entry level lateral with Medical Writing experience.
Skills and Capabilities
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
Education
- Graduate/Masters in Life Sciences
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.