Medical Writer, Associate Director
Ascendis Pharma, Denmark

Are you passionate about supporting clinical development programs and regulatory submissions? Do you have experience authoring and managing regulatory/clinical documents?

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

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company with an independent pipeline of long-acting prodrug therapies that address unmet patient needs.

As our new Medical Writer you will be joining the Global Regulatory Communication team based in both Denmark and US.

The team is responsible for preparing quality communications about our clinical data, with a regulatory focus. We are a growing team of dedicated and skilled medical writers, where a collaborative and supportive environment is key. Your passion for and experience in medical writing and your adaptive working style provide the opportunity to make great contributions to the projects.

You will report directly to Victoria Fuller-Mikkelsen who is based in Hellerup, Denmark.

Your responsibilities:

• Planning, developing, and/or providing oversight of clinical regulatory documents, including CSRs, Investigator Brochures, marketing authorization applications, 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.
• Assisting with the management of external vendors or consultants.
• Preparing or reviewing documents for public release, including lay language summaries.

Your Profile:

You hold a relevant academic degree preferably Master’s level and 7+ years of experience within the pharma industry and 3+ years in Medical Writing.

Furthermore, you have:

• Experience in authoring to prepare clinical/regulatory documents.
• Excellent verbal and written communication skills with the ability to effectively communicate with a variety of teams and individuals.
• Ability to understand, interpret and communicate data from clinical trials.
• Proven ability to work with and lead cross-functional, global teams of contributors.
• English at a professional level, both written and spoken.
• An interest in developing and improving medical writing-related processes.

As a person, you are a strong team player, proactive in nature and have a can-do attitude.

As we are taking new steps towards developing best-in-class therapeutics for patients with rare diseases we are looking for people who possess an entrepreneurial mindset who can handle ambiguity, analyze, and create clarity and desires to be part of an organization where everything isn’t set in stone. We rely on you to help us shape the cement.

The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere.

Travel: approx. 10 days per year.

Place of work: Ascendis Pharma headquarter resides in a modern and wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.

For more details about the position or the company, please contact Victoria Fuller-Mikkelsen, Senior Director, Global Regulatory Communication on or visit out website www.ascendispharma.com.

All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.

Benefits

• You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
  
• Laptop, iPhone, paid internet, and home office equipment.
  
• A thorough and structured onboarding program.
  
• To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.
• Soft drinks, fresh fruit, and a wide variety of snacks every day, no strings attached.
• To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we find a way to help you grow.

Job Rewards and Benefits