Senior Medical Writer at Novo-nordisk – VACANCY – APPLY NOW
Role : Senior Medical Writer
Company : Novo nordisk
Category : Clinical Development and Medical
Location : Bangalore, Karnataka, IN
Department : Clinical Reporting GBS
The position
The key responsibilities in this position will be to perform medical writing tasks for trial and/or non-trial activities within clinical reporting including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Layperson Summary (LPS), Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews. The tasks, to a large extent, will have to be performed independently. You will have to communicate the clinical data in a clear and concise manner.
- Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally.
- You will contribute to process improvements, knowledge sharing, skill building, and mentor and train other medical writers as needed. You will have to maintain good relationship with the stakeholders and colleagues.
- Responsible in order to meet timelines, the medical writer must be good at planning own work and be proactive when problems arise and seek help and advice from relevant people within GBS as well as within HQ.
- You will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved.
- Frequent travelling abroad to attend meetings in HQ and CMRs, and conference and courses world-wide, will be the part of the job.
Qualification
You are expected to have the below skills and knowledge for the role of Senior Medical Writer at Novo nordisk :
- Graduate (PhD, MSc., M Pharm, or equivalent).
- 5+ years of experience as medical writer or other relevant work experience.
- Experience in CSR, protocol, IB, informed consent and clinical summaries and clinical overviews.
- Experience working within a global setting.
- Experience from the pharmaceutical /CRO industry.
- Strong understanding of external requirements related to regulatory documents.
- Works independently on smaller tasks.
- Strong analytical skills.
- Committed, persistent and accountable.
- Able to manage variable workload.
- Able to handle numerous tasks simultaneously.
- Prioritizes own tasks but may need to seek advice.
- Requires good communication and analytical skills.
Deadline to apply for the role of Senior Medical Writer at Novo-nordisk is 30th Sep 2023
Here few interview question and answers for the role of Senior Medical Writer at Novo-nordisk :
Interview Question 1: Can you provide an overview of your experience as a Medical Writer and how it aligns with the responsibilities outlined in this role?
Answer: Certainly. I have over 8 years of experience as a Medical Writer, during which I have worked extensively on various clinical reporting documents, including Protocols, Clinical Trial Reports (CTRs), Non-interventional Study Reports (NSRs), Layperson Summaries (LPS), Investigator Brochures (IB), Regulatory response documents (Q&A), Clinical Summaries, and Clinical Overviews. My experience spans both trial and non-trial activities, and I am well-versed in communicating complex clinical data in a clear and concise manner. Working independently on several medical writing projects has honed my skills in meeting deadlines, ensuring accuracy, and collaborating effectively with stakeholders and colleagues globally.
Interview Question 2: As a Senior Medical Writer, part of your responsibility is to mentor and train other medical writers. Can you describe your approach to training and how you ensure effective knowledge sharing?
Answer: When mentoring and training other medical writers, I adopt a collaborative and supportive approach. I begin by understanding their existing skills and knowledge gaps, tailoring the training accordingly. I create comprehensive training modules and resources to provide them with a strong foundation in medical writing principles and best practices. Additionally, I encourage a learning environment where questions and doubts are welcomed, fostering an atmosphere of continuous improvement. Regular feedback and constructive critiques on their work help them understand areas for improvement and growth. Through regular knowledge sharing sessions, I also keep the team updated on the latest industry trends and regulatory requirements.
Interview Question 3: This role involves frequent travel abroad for meetings, conferences, and courses. How do you manage your workload and maintain productivity during such periods?
Answer: Traveling for meetings and conferences is indeed an exciting aspect of this role. To manage my workload effectively during such periods, I plan ahead and prioritize tasks based on deadlines and urgency. Before traveling, I ensure that ongoing projects are appropriately handed over to team members or that key milestones are achieved. I also maintain open communication with stakeholders and colleagues to manage expectations and provide timely updates on project progress. While abroad, I make use of any available downtime to work on tasks that can be accomplished remotely, ensuring that productivity remains consistent despite being away from the office.
Interview Question 4: In this position, you will be required to challenge expert contributors on the quality of their written contributions. How do you approach such interactions while maintaining a positive and collaborative environment?
Answer: Challenging expert contributors on their written contributions is essential for upholding the high standards of clinical documents. I approach such interactions with diplomacy and a focus on collaboration. I always strive to ensure that my feedback is constructive and supported by evidence or relevant guidelines. It’s crucial to emphasize that the goal is to enhance the quality of the documents collectively and to achieve the best possible outcomes. By acknowledging their expertise and highlighting areas where improvements can add value to the documents, I maintain a positive and respectful environment, fostering a spirit of continuous improvement.
Interview Question 5: As a Senior Medical Writer, how do you stay updated on external requirements related to regulatory documents, especially considering the dynamic nature of the pharmaceutical industry?
Answer: Staying updated on regulatory requirements is paramount in the pharmaceutical industry. I regularly engage in continuous learning and professional development by attending industry conferences, workshops, and webinars. Additionally, I actively participate in relevant forums and discussion groups to exchange knowledge with peers. Subscribing to reputable scientific journals and regulatory publications helps me stay informed about changes in guidelines and requirements. Collaborating with colleagues and regulatory experts within the organization also allows me to gain valuable insights and updates on best practices in medical writing, ensuring that I stay current with the latest external requirements.
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