Director, Medical Writer

Are you passionate about the communication of clinical data in a regulatory context? Do you have experience in medical writing?

If so, now is your chance to join Ascendis Pharma as our new Medical Writer.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Medical Writer to join our growing dedicated and skilled team. The team is responsible for preparing quality communications about our clinical data, with a regulatory focus. Your passion for and experience in medical writing and your collaborative working style provide the opportunity to make outstanding contributions to our programs.

This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results.

As our new Medical Writer you will be joining the Global Regulatory Communication team, which has team members based in both Denmark and US. You will be based in Hellerup, Denmark.

Your key responsibilities will be:

• Planning, developing, and/or providing oversight of diverse clinical regulatory documents, including CSRs, Investigator Brochures, NDA/BLA/MAA, PIPs, briefing packages, responses to agency questions, and other document types.

• Representing Medical Writing on cross-functional project teams and providing advice and guidance on regulatory document requirements and presentation of data.

• Leading or contributing to the development/optimization of processes, systems, templates, and standards.

• Preparing or reviewing documents for public release, including lay language summaries.

Qualifications and Skills:

You hold a relevant academic degree (preferably Master’s or higher level), have experience within the pharma industry, and 10+ years within Medical Writing.

Furthermore, you have:

• Experience leading or having a major role in submission preparation (NDA/BLA/MAA).

• Proven ability to work with and lead cross-functional, global teams of contributors.

• Experience in authoring a variety of clinical and regulatory documents.

• Excellent verbal and written communication skills with the ability to effectively communicate with a variety of teams and individuals, across time zones.

• Ability to understand, interpret and communicate data from clinical trials.

• English at exceptional professional level, both written and spoken.

• An interest in developing and improving medical writing-related processes, including digital/AI solutions.

Key competencies:

To succeed in this role, you must be a strong team player, proactive in nature, and with a can-do attitude. You like to operate in an environment with opportunities to have high impact. You are comfortable working independently and can take decisions in complex situations.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

Travel: can be 5-10 days per year.

Office: Hellerup, Denmark

Apply now.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.   

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated. 

For more details about the position, please contact [email protected].

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.