Latest Job for Life Science Graduates at Novartis – Regulatory Writer Role – Apply Now
Latest Job for Life Science Graduates at Novartis – Regulatory writer Role – Check out the details below and apply
Role: Regulatory writer
Job ID: 382154BR
Job Type: Full Time
Work Location: Hyderabad, AP
Functional Area: Research & Development
Job Description
Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.
Your responsibilities include, but are not limited to:
- To author and review high quality clinical and safety documents: non-registration clinical Study Reports (CSR), Development safety Update Reports (DSUR), Risk Management Plans (RMP). Core member of clinical Trial Team/participate in safety Management Team.
- Actively participate in planning of data analyses and presentation used in CSRs.
- Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May Act as Program Writer ensuring adequate medical writing resources are available for assigned Program and consistency between documents.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements:
- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- ≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
- Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Knowledge of process for and some experience in global registering of drugs (simple submissions).
- Excellent communication skills (written, verbal, presentations). Very good understanding of biostatistics principles.
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Here are some interview questions and sample answers for the role of Regulatory Writer at Novartis:
- Can you describe your experience with authoring clinical and safety documents, such as CSRs, DSURs, and RMPs?Sample Answer: In my previous role as a Regulatory Writer, I had the opportunity to author and review various clinical and safety documents. I have experience in preparing non-registration CSRs, DSURs, and RMPs, ensuring they meet both internal company standards and external regulatory guidelines. This involved collaborating closely with cross-functional teams to gather and interpret data, allowing me to accurately convey critical information in these documents.
- How do you stay up-to-date with the latest regulatory guidelines and changes in the pharmaceutical industry?Sample Answer: Staying informed about regulatory updates is crucial in this role. I regularly attend industry seminars, webinars, and conferences, where experts discuss the latest regulatory changes and best practices. Additionally, I subscribe to reputable regulatory news sources and am an active member of professional organizations related to regulatory affairs. This continuous learning process ensures that I remain current with industry trends and guidelines.
- Can you provide an example of a challenging situation you faced in ensuring document compliance with regulatory standards, and how did you address it?Sample Answer: In a previous project, we encountered a complex regulatory change that required us to update multiple documents already in progress. To address this challenge, I initiated a comprehensive review of all affected documents, identified the necessary revisions, and coordinated with cross-functional teams to implement these changes efficiently. Effective communication and project management skills played a vital role in ensuring that all documents were updated promptly and in compliance with the new regulations.
- Describe your experience in collaborating with cross-functional teams, including Statistics, Data Management, and Clinical Development. How do you ensure effective teamwork and communication in such collaborations?Sample Answer: Collaborating with cross-functional teams is a fundamental aspect of my role. I actively engage with colleagues from different departments by participating in regular meetings, providing clear project updates, and seeking their input and feedback. I also ensure that communication lines are open, promoting an environment where all team members feel comfortable sharing their insights and concerns. Effective teamwork is not just about completing tasks; it’s about fostering a collaborative spirit that leads to successful project outcomes.
- What strategies do you use to ensure the quality and accuracy of your written documents, especially when dealing with complex scientific and regulatory content?Sample Answer: To ensure the quality and accuracy of my written documents, I follow a structured approach. I start by thoroughly understanding the scientific and regulatory context of the document. I then create detailed outlines, collaborate with subject matter experts for content validation, and perform multiple rounds of review and editing. Additionally, I use specialized software tools for document management and quality control. Finally, I always keep the target audience in mind, aiming to present complex information in a clear and comprehensible manner.
ALL THE BEST !
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