Job Description

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. The team 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. The position The key responsibilities in this position will be to perform medical writing tasks of high complexity and act as project manager. Plan, develop and oversee regulatory documents across all phases including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Meeting packages and briefing book, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews. In this position, you need to set direction, drive discussion, ensure decisions are taken and influence and implement project strategy. You will have to communicate the clinical data in a clear and concise manner. 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. Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Assume role as Project Medical Writer (PMW) , Clinical Submission Team Lead (CST) for assigned project. 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. Support execution of Clinical Reporting strategy and vision in line with the leadership team. You will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved. Qualification You are expected to have the below skills and knowledge: Graduate (PhD, MSc., M Pharm, or equivalent). 10+ years of experience as medical writer or other relevant work experience. Experience in regulatory medical writing, Clinical study Report( CSR), protocol, IB, informed consent and clinical summaries and clinical overviews. Excellent understanding of clinical development and regulatory processes and requirements. Experience working within a global setting. Experience from 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. Requires good communication and analytical skills. Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. Established record of being a proactive team-player and able to deliver on time and with high quality.

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