Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Medical Writing Specialist
About the department
The Clinical Reporting unit in Global Business Service 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 master/PhD in life sciences, pharmacology, medicine, etc. The team is full of commitment, passion, skills, and talent with broad knowledge of 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 the distribution of documents (CONNECT portal) and largely contributes to NN’s regulatory commitments by being involved in public disclosure activities.
Job Description
The position
As a Medical Writing Specialist, you will be responsible for performing medical writing tasks of high complexity and acting as a project manager. Your role will involve planning, developing, and overseeing regulatory documents across all phases of clinical development. This includes but is not limited to, the preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Meeting packages and briefing books, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries, and Clinical overviews. In this role, you will be expected to set direction, drive discussions, ensure decisions are made, and influence and implement project strategy.
As a Medical Writing Specialist at Novo Nordisk, you will have the responsibilities to:
• Communicate clinical data clearly and concisely, contributing to process improvements, knowledge sharing, and skill building. Mentor and train other medical writers as needed, while maintaining 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, being proactive when problems arise, and seeking help and advice from relevant individuals within GBS and HQ.
• Support execution of Clinical Reporting strategy and vision in line with the leadership team. Challenge expert contributors on the clinical documents where the quality of their written contribution could be improved.
• Ensure the accuracy and compliance of documents with regulatory standards and guidelines through expertise and attention to detail.
Candidate Profile
• 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.
• Experience in the pharmaceutical/CRO industry.
• Strong understanding of external requirements related to regulatory documents.
• Strong analytical skills, Excellent communication and presentation skills.
• Committed, persistent, and accountable. Able to handle numerous tasks simultaneously.
• Demonstrated ability to identify best practices and create improvements in methods, techniques, approaches, etc.
• Proven track record of being a proactive team player and delivering on time and with high quality.
Additional Information
Qualification : PhD, MSc., M.Pharm
Experience : ≥10+ years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Development
End Date : 30th May 2024
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