M Pharma job opening 2023, Medical writer job opening 2023, Novo Nordisk job opening 2023, Pharmacy job opening 2023, Intrested and eligible candidates may checkout all the details on the same below:
Job Title: Medical Writer – CER
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
You are expected to have the below skills and knowledge:
- Graduate (PhD, MSc., M Pharm, or equivalent).
- 2+ years of experience as medical writer or other relevant work experience.
- Experience working within a global setting.
- Experience from the pharmaceutical /CRO industry.
- Strong understanding of external requirements related to regulatory documents.
- Good communication skills.
- Works independently on smaller tasks.
- Strong analytical skills.
- Committed, persistent and accountable.
- Able to plan manage variable workload &handle numerous tasks simultaneously.
- Prioritizes own tasks but may need to seek advice
About the department
The Clinical Reporting unit in GBS has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 6-7 years, since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers, Disclosure Medical Writers, Publishers and Document Controllers with Masters/PhD in life sciences, pharmacology, medicine, etc. Theteam is full of commitment, passion, skills, and talent with broad knowledge on different therapeutic areas and regulatory requirements for submissions. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. Apart from writing and publishing regulatory documents, the team is also responsible for distribution of documents (CONNECT portal) and largely contributes to NN’s regulatory commitments by being involved in Public disclosure activities.
As a Medical Writer you will ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Furthermore, you will communicate across the time zones and in different professional environments. This job requires good communication and analytical skills. In order to meet timelines, you 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 Head Quarters (HQ). Additionally, you will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved.
You are entrusted to fulfil the following responsibilities:
- We primarily need Medical Writers with 2+ years of experience in writing clinical evaluation reports (CER) and Clinical evaluation plans (CEP) and demonstrated understanding of clinical research, the drug/device development process, and applicable regulatory guidelines.
- You will be performing 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) and Regulatory response documents (Q&A).
- You will have to communicate the clinical data in a clear and concise manner.
- You will contribute to knowledge sharing and maintain good relationship with the stakeholders and colleagues.
- You should ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. You will communicate across the time zones and in different professional environments.
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