Novo Nordisk Medical Writer Vacancy 2020 – Apply Online
Novo Nordisk Pharma Job – Pharma Apply Online. Postgraduate and PhD pharma candidates apply. candidates are eligible to apply online for a medical writer post. Associate analyst professional position that is available at Novo Nordisk, which is one of the world’s most successful pharmaceutical companies
Job Title: Medical Writer
Qualifications
They are expecting you to hold the below skills and knowledge:
- PhD, MSc., M Pharm, or equivalent
- 2+ years of experience in Medical Writing with clinical trail disclosure which is Mandate
- 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
The position
- As a Medical Writer, you will be responsible to Perform medical writing tasks like preparation or review of protocol registration and results in disclosure of clinical trials to different registries. You will be responsible for Justifying the tables and anonymization reports for redacted documents by ensuring its timely submission.
- Additionally, you must contribute ongoing process improvements in a cross-functional team, global collaboration and sharing best practices and knowledge. And, you will require to maintain up-to-date knowledge on global regulatory requirements, competencies within relevant therapeutic and other policies related to clinical trial disclosure and transparency.
- Finally, you will also be involved in relevant meetings, training sessions, internal or external marketing or medical activities like expert meetings, lectures and conferences and seminars in the department, competency anchor and relevant projects.
About the department
- The Medical Writing unit 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. It is a dynamic mix of young, enthusiastic, qualified and skilled Medical Writers and Publishers who are full of commitment, passion, skills and talent. The team is a right blend of professionals with Masters/PhD in pharmacology, medicine, toxicology etc. with broad background knowledge on different therapeutic areas and medical basics. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications.
- The unit witnessed a steep learning curve with improved complexities of deliverables and now contributes largely to different project areas, with extended expertise to non-clinical and public disclosure activities. The deliverables of Medical Writing Department currently include writing, reviewing, and publishing of clinical trial reports (CTR) for Phase 1 to 4 trials, non-interventional study reports (NSR), IMPDs, clinical overviews, expert overviews, IB updates, manuscripts for publications in peer-reviewed journals, involvement in submission subtasks (Protocol deviations, narratives, CRF trackers) and involvement in Adcomm slides preparation/trial-specific slide packages. This team is also involved in non-clinical document publishing and largely contributes to NN’s regulatory commitments by being involved in Public disclosure activities including layperson summaries.
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