Principal Medical Writer/Associate Director, Medical Writing
Ascendis Pharma, Denmark

Join the Global Regulatory team in a leading and fast-growing biotech company

Ascendis Pharma is in the process of expanding its pipeline with more drug candidates and commercialization of our first EMA and FDA approved product. We are looking for a new colleague to join the Regulatory Writing team responsible for document development and management.

You will report to the Director, Global Regulatory Writing within Global Regulatory Affairs department.

Ascendis Pharma A/S is a visionary and ambitious company and offers you an opportunity to become involved in the development of ground-breaking therapies on our journey towards becoming a leading rare disease company.

Primary responsibilities:

• Plans, develops, and/or provides oversight of clinical/regulatory documents, included but not limited to CSRs (all phases), Investigator Brochures, CTD summaries, PIPs, briefing packages, responses to agency questions according to ICH guidelines, regulatory requirements, and internal document standards.

• Represents Regulatory Writing on cross-functional project teams. Participates in regulatory teams, providing advice/guidance to the team on regulatory document requirements and optimal presentation of data
• Works collaboratively with functional contributors (Clinical Development, Pharmacovigilance, Biometrics, Regulatory Affairs, Regulatory Operations, others), ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation, and in accordance with project timelines.
• Assists with the coordination of the compilation of final documents provided by other functions, the coordination and preparation of document redaction initiatives, as well as clinical trial disclosure initiatives.
• Contributes to development of document and process standards, template development, and other aspects of document management.
• Assists with the management of external vendors or consultants to ensure document compliance with guidances, as well as quality, and adherence to timelines.
• Contributes to other non-regulatory writing activities as needed.

Criteria of success in the role will be to create regulatory documentation in partnerships with key stakeholders internally in Ascendis, and to ensure that strategic business goals are met through the sharing of knowledge, and expertise.

You hold a university degree within Natural Science or a related field. You have at least 10 years of documented professional experience from a Medical Writing position within the pharmaceutical (Sponsor or CRO) industry. You have excellent collaboration and communication skills, a proven ability to build trust and respect within the organization and you are highly committed to deliver outstanding results. You are a highly motivated individual who enjoys being challenged, working in collaborative environments and at the same time being self-driven. You think creatively and develop creative solutions and you have a hands-on attitude, and professional work ethic. You will actively contribute to the established teamwork culture, supporting and sharing with your colleagues. You are proficient in English at a professional level, both written and spoken.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

Travelling: 15-25 days per year.

Place of work: This role is based at Ascendis Pharma HQ which resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.

For more details about the job or the company, please contact Bradley Scheetz, Director, Regulatory Writing at . All applications must be submitted in English and are treated confidentially.

We will review applications on an ongoing basis, so please do not hesitate to apply

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