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CMC Technical Writer

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

Ascendis Pharma is expanding its CMC resources to support the development projects and they are now looking to hire a passionate CMC Technical Writer to provide support for writing of regulatory documents to the late stage projects.

As CMC Technical Writer at Ascendis Pharma you will be responsible for (co)-authoring CTD Module 3 documents for regulatory submissions for the late stage development projects (BLA, NDA/MAA, INDs/IMPDs), as well as other regulatory documents needed for regulatory interactions (documents for End-of-Phase 2, pre-BLA, pre-IND, responses to information requests from regulatory bodies etc.) within the CMC area. You will coordinate writing and review cycles within the CMC Drug Substance & Analysis team, as well as having interactions with colleagues in Drug Product & Device Development, Regulatory Affairs and Product Supply, including authoring and reviewing documents for manufacturing processes, analytical and stability sections. You will ensure the accuracy, interpretation and clarity of written technical documents and ensure all documents will meet regulatory requirements. You will report to the Vice President CMC Drug Substance & Analysis and join a team of 10 highly experienced CMC professionals (3 organic chemists and 7 analytical chemists).

Success criteria in this role will be to (co)-author regulatory documents with attention to details adapted to the development phase, and to ensure a timely review and approval of submission documents within the designated review teams.

Your main areas of responsibilities are:

  • Authoring and reviewing CMC Module 3 documents
  • Project management/coordination of technical writing and reviewing activities between internal CMC teams and CMOs/CROs
  • Provide direction on the CMC content of documents for BLA/NDA/MAA submission as well as INDs/IMPDs
  • Ensure that the documentation is of highest quality and any issues are highlighted to internal or third-party stakeholders in a timely manner
  • Maintain up-to-date knowledge of current and emerging regulations, guidance documents and industry standards 

You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or similar.

Your qualifications are at least 5 years of documented experience within CMC development activities including writing of regulatory submission documents. You must be able to understand experimental procedures, data and concepts relating to CMC development for biologics, peptides and small molecules. You possess strong written and oral communication skills to summarize studies from reports and GMP documentation, and a demonstrated ability to document information in a clear and concise manner. Experience with supporting a BLA/NDA filing is preferred.

Furthermore, you are proficient in English at a professional level, both written and spoken, and you master MS Office at a professional level. Experience with MS Projects, or other project tools, is an advantage.

You are a highly motivated individual who enjoys being challenged and are passionate about working in collaborative, complex and fast-paced environment. Strong interpersonal skills are necessary, as you will serve as a major contributor within the team of CMC colleagues also contributing to the regulatory documents. Finally, being well-organized and paying attention to detail is a prerequisite – combined with a high sense of urgency.

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 together with highly skilled and experienced colleagues to advance the exciting product pipeline.

Travelling: 10 – 20 days per year.

Domicile: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.

For more details about the job or the company, please contact Research Consultant Elisabeth Haun, Unique Human Capital on M +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
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