Syngene BSc, MSc Life Sciences Medical Writer Job Opening, Apply Online

Syngene Medical Writer Job Opening For BSc, MSc Life Sciences

Syngene Medical Writer Job Opening For BSc, MSc Life Sciences. MSc, BSc Life Sciences Job in Syngene, Bangalore. Syngene is hiring Life Sciences candidates for Senior Executive – Medical Writer job.

The five possible interview questions that can be asked in the technical round for Senior Executive – Medical Writer position, along with their answers are posted below:

Designation: Senior Executive – Medical Writer

Job Location: Bangalore

Requisition ID: 54332

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

Behavioural 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.

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Here are five possible interview questions that can be asked in the technical round for Senior Executive – Medical Writer position, along with their answers:

1. Question: Can you describe your experience in developing clinical trial-related documents, such as protocols, Clinical Study Reports (CSRs), and Informed Consent Documents (ICDs)? Answer: In my previous role as a Medical Writer, I have independently developed and finalized various clinical and scientific documents, including protocols, CSRs, ICDs, and other regulatory documents. I am well-versed in covering different therapeutic areas and all phases of clinical research.
2. Question: How do you ensure the quality and compliance of medical writing deliverables with regulatory guidelines and client requirements? Answer: I follow department Standard Operating Procedures (SOPs), client style guides, and applicable regulatory guidelines to ensure compliance. Additionally, I perform documented quality control (QC) checks on medical writing deliverables and address any findings promptly.
3. Question: Can you explain your approach to literature search and review for obtaining background information for developing scientific content? Answer: When conducting literature searches, I use reliable databases and sources to gather relevant scientific information. I thoroughly review the literature to obtain the necessary background information that supports the development of scientific content in clinical documents.
4. Question: How do you manage timelines and prioritize your workload to deliver projects on time? Answer: Effective time management is crucial in my role as a Medical Writer. I prioritize tasks based on their deadlines and importance, and I utilize project management tools to track progress and ensure timely completion. I am proactive in communicating with stakeholders to address any potential delays and manage expectations.
5. Question: Have you worked with electronic submission formats like the Electronic Common Technical Document (eCTD) modules? How familiar are you with their requirements? Answer: Yes, I have experience working with eCTD modules for regulatory submissions. I am well-versed in the specific requirements and formatting guidelines associated with eCTD submissions. I ensure that the content is appropriately organized and structured to meet the regulatory standards for electronic submissions.

Remember to adapt these questions and answers to your own experience and knowledge while preparing for the interview. Good luck!

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