Novartis Scientific Writer Job For Life Sciences Candidates, Apply Online
Novartis Scientific Writer Job For Life Sciences Candidates, Apply Online. Novartis calling for a Lifescience Job as Scientific Writer. Interested candidates can go through the below details and apply for the Lifescience Job as Scientific Writer at Novartis-Apply online
Position – Scientific Writer II
Job ID – 376012BR
Work Location – Hyderabad, AP
Responsibilities –
- To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives
- Act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable) Timely preparation of publications to satisfy regulatory requirements for publication of clinical trial results, to increase customer awareness of company products, and to support marketing activities.
Minimum requirements:
Essential:
- Minimum: Life-science degree or equivalent B.Sc./equivalent with 4 years Clinical Research (CR) experience, M.Sc./M.Pharm + 2 years of CR experience, Desired – Doctoral degree, Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 1 year of CR experience, MBBS/equivalent + 1 year of CR experience
Desirable requirements:
• Excellent written and oral English.
Hi there, Attaching some of the interview questions and answers that you can expect when you are attending the interview for the Scientific writer job. Prepare well and do your best in your interview.
Can you tell us about your experience in scientific writing and editing clinical and safety documents? Suggested answer: I have a strong background in scientific writing and editing, specifically in clinical and safety documents. I have experience in writing non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents, and Patient Narratives. I have worked on various projects where I have effectively communicated complex scientific information in a clear and concise manner.
How do you ensure the quality and compliance of clinical and safety documents with internal company standards and external regulatory guidelines? Suggested answer: I understand the importance of maintaining quality and compliance in clinical and safety documents. To ensure this, I carefully review the internal company standards and external regulatory guidelines relevant to the specific document. I pay close attention to the formatting, content, and language used, making sure it aligns with the required standards. Additionally, I collaborate closely with cross-functional teams, acting as a documentation consultant, to address any discrepancies and ensure adherence to the guidelines.
Can you describe your experience in liaising between cross-functional teams and publishing teams to ensure timely delivery of final documents for publishing?
Suggested answer: In my previous role, I have successfully acted as a liaison between cross-functional teams, such as Clinical Trial Teams (CTTs), and publishing teams. I understand the importance of timely document delivery for publishing purposes. I ensure effective communication between the teams, providing regular updates on the progress of document preparation and addressing any potential bottlenecks. By coordinating efforts and setting clear timelines, I facilitate the smooth and timely delivery of final documents for publishing.
How do you handle technical complaints, adverse events, and special case scenarios related to products, and what is your approach to reporting them within the required timeframe? Suggested answer: When it comes to technical complaints, adverse events, and special case scenarios related to products, I follow a systematic approach. I promptly gather all the necessary information and ensure a thorough understanding of the situation. I then report these incidents within 24 hours of receipt, as required by company protocols and regulatory guidelines. I pay close attention to detail and accuracy in my reporting, ensuring that all relevant information is included while maintaining confidentiality and adhering to data privacy regulations.
How would you approach the preparation of publications to satisfy regulatory requirements, increase customer awareness, and support marketing activities?
Suggested answer: In preparing publications, I recognize the importance of satisfying regulatory requirements, increasing customer awareness, and supporting marketing activities. To achieve these goals, I would begin by thoroughly researching and understanding the regulatory guidelines pertaining to publication of clinical trial results. I would collaborate with cross-functional teams to gather the necessary data and insights, ensuring the accuracy and integrity of the information presented. I would then work closely with internal stakeholders, such as regulatory affairs and marketing teams, to ensure the publications align with the company’s objectives and strategies.
Can you highlight your proficiency in both written and oral English?
Suggested answer: I have excellent proficiency in both written and oral English. Throughout my academic and professional career, I have consistently demonstrated strong communication skills. I have experience in producing high-quality written content, adhering to grammar, style, and formatting guidelines. Additionally, I am confident in my ability to effectively articulate complex scientific concepts in a clear and concise manner during oral communication. I prioritize clarity and precision in my language, ensuring effective communication with diverse audiences.
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