Hiring Medical Writing Specialist At Novo Nordisk -Apply Now
About Company
The Clinical Reporting unit in Global Business Service at Novo Nordisk has seen tremendous growth and has become an integral part of the Global Clinical Reporting community since its inception in 2011. The team is a dynamic mix of skilled Medical Writers, Disclosure Medical Writers, Publishers, and Document Controllers with master’s/PhD degrees in life sciences, pharmacology, medicine, etc. With broad knowledge of various therapeutic areas and regulatory requirements, the team drives clear and impactful communication on the conduct and outcome of clinical trials. They are also responsible for the distribution of documents and public disclosure activities.
Position Name :Medical Writing Specialist
Organization :Novo Nordisk
Qualification:B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Experience:10 year
Salary:17.6 Lakhs per year
Location:Bangalore
As a Medical Writing Specialist, you will be responsible for performing complex medical writing tasks and acting as a project manager. This role involves planning, developing, and overseeing regulatory documents across all phases of clinical development, including Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Meeting packages, Investigator Brochures (IB), Regulatory response documents (Q&A), Clinical summaries, and Clinical overviews. You will set direction, drive discussions, ensure decisions are made, and influence and implement project strategies.
Key Responsibilities:
- Communicate clinical data clearly and concisely.
- Contribute to process improvements, knowledge sharing, and skill building.
- Mentor and train other medical writers as needed.
- Maintain good relationships with stakeholders and colleagues.
- Ensure timely, clear, and proactive communication and collaboration with stakeholders and colleagues globally.
- Assume the roles of Project Medical Writer (PMW) and Clinical Submission Team Lead (CST) for assigned projects.
- Meet timelines by planning work effectively and being proactive when problems arise.
- Support the execution of Clinical Reporting strategy and vision in line with the leadership team.
- Challenge expert contributors to improve the quality of their written contributions.
- Ensure the accuracy and compliance of documents with regulatory standards and guidelines.
Qualifications:
- Graduate degree (PhD, MSc., M Pharm, or equivalent).
- ≥10 years of experience as a medical writer or other relevant work experience.
- Experience in regulatory medical writing, including Clinical Study Reports (CSR), protocols, Investigator Brochures (IB), informed consent forms, clinical summaries, and clinical overviews.
- Excellent understanding of clinical development and regulatory processes and requirements.
- Experience working in a global setting and in the pharmaceutical/CRO industry.
- Strong analytical skills and excellent communication and presentation skills.
- Committed, persistent, and accountable with the ability to handle numerous tasks simultaneously.
- Demonstrated ability to identify best practices and create improvements in methods, techniques, and approaches.
- Proven track record of being a proactive team player and delivering high-quality work on time
- Application Link
- https://chat.whatsapp.com/DO9PMPj2H3K4SikyHri52x
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