Senior Regulatory Content Writer

At [xxxxx], we have a passion for improving patients’ lives all over the world. Do you want to help us bring this passion to life, while further developing your expertise within scientific communication and act as an integral part of impactful agile teams?
If yes, then apply for the Senior Regulatory Content Writer position and become the newest member of our newly established Content Management Team in Clinical Reporting. The position
As a Senior Regulatory Content Writer in the Content Management Team, you will be an integral part of supporting the operational implementation of one of our newly developed digital products, NovoScribe, which has been developed to produce clinical study reports (CSRs). NovoScribe is an automated authoring platform developed using a structured authoring approach and natural language processing. It fosters a standardized, validated, and methodical approach to document creation. NovoScribe utilizes automated integration of statistical results by incorporating systematic tagging, topic-based authoring and enables reuse of standardized texts across trials. The aim of NovoScribe is to transform the way we write documents (eg. clinical study reports) by introducing automation and natural language processing. You will be working in a transformative and innovative team, which is leading the pharmaceutical industry in automated document creation. Your key responsibilities include:

Collaborate on the development of regulatory content following established guidelines and SOPs

Plan content creation and establish timelines for document production and review

Evaluate documents for coherence, precision, scientific rigor, and consistent information and messaging

Maintain the text library in the database and expand it to include more disease areas

Provide input to the improvement of the database and play a pivotal role in functional and cross-functional teams

Actively engage in improving best practices and innovating the way we work

Maintain an updated understanding of essential regulatory, scientific, and medical subjects pertinent to drug development, designated products, and specific disease/therapeutic domains

As a Senior Regulatory Content Writer, you will be an integral part of the team that is leading the way in automated document creation. You will have the opportunity to contribute to the transformation of the way we write documents in the pharmaceutical industry by actively engaging in improving best practices and innovating the way we work. Qualification To fulfill this role, you have:

A master’s degree within natural sciences (MSc., MSc. Pharm. or equivalent), preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry

Demonstrated ability to produce clear, high-quality scientific writing in the English language

Experience of authoring clinical study reports (CSRs)

Experience of using and maintaining databases

Ability to work effectively on cross-functional, geographically diverse teams, establishes strong collaborative relationships

Project management skills, consistently achieves multiple tasks and goals on-time

In addition to the technical skills, we value personal contributions and teamwork. Therefore, we are looking for someone who can independently analyse and synthesize data and non-clinical and clinical concepts from a broad range of disciplines, and challenge the status quo. The candidate should also have strong interpersonal, verbal, and written communication skills, be proficient in English, and comfortable presenting topics to a larger audience. Furthermore, the ideal candidate should be able to work independently with a positive can-do attitude, think through problems clearly and logically, and adapt to changing conditions. At [xxxxx], we value both hard and soft skills, and we believe that the right candidate should possess a combination of both to maintain a good work environment. About the department
You will join us in Clinical Reporting, the medical writing function at [xxxxx] – currently comprising around 150 medical writers worldwide. We are part of [xxxxx] Development and anchored in the Submission & Life Cycle Management area. Development is responsible for managing clinical drug development and submissions to health authorities worldwide, from the early development phases to market authorisation. Our supportive culture drives business transformation and we value continuous learning, being bold and striving for simplicity. Clinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials and our main task is to communicate clinical data in a clear and concise manner. Working at [xxxxx]
Founded in Denmark in 1923, [xxxxx] has become one of the world’s leading healthcare companies. At [xxxxx], we are committed to driving change to defeat diabetes and other serious chronic diseases. To fulfil this purpose, we pioneer scientific breakthroughs, expand access to our medicines, and work to prevent and ultimately cure disease. That said, we are anything but linear. With us, your skills, commitment, and ambition help us change patients’ lives worldwide. In exchange, we offer you a rewarding and purpose-driven culture with talented and diverse co-workers. Therefore, your professional and personal development is essential for us, and in [xxxxx], the sky is the limit for career opportunities.

Contact
For further information, please contact Inger Ødum Nielsen, Team Lead in Content Management Team, Content Digitalisation, on +[xxxxx]. Deadline
23 June 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.