Be the new
CMC Technical Writer
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs.
Zealand Pharma A/S (Zealand) is looking for an experienced CMC Technical Writer to provide support for writing of regulatory documents to our development projects.
As CMC Technical Writer at Zealand you will be responsible for (co)-authoring documents for regulatory submissions for our late stage development projects within the CMC and Device area. You will also coordinate writing and review cycles and keep the document planner updated. You will ensure the accuracy and clarity of the regulatory documents and ensure that all documents meets relevant regulatory requirements in collaboration with Regulatory Affairs. Clinical trial appplications and authority meeting packages will also be part of the responsibility.
You will report to the Vice President of Device & Manufacturing Sciences and join a team of 10 highly experienced CMC professionals, responsible for late-stage development & manufacturing and for writing of regulatory documentation. You will be working in project teams together with other development functions. Since Zealand is using CMOs and CROs, coordination with external partners is a key part of the job alongside internal Zealand collaboration.
You will be part of an innovative and agile biotech company focused on the discovery, design, development and commercialization of innovative peptide-based medicines.
The successful candidate will be responsible for CMC and Device documents included in regulatory submissions, during Q&A and subsequent lifecycle management activities:
The successful candidate will have:
- Authoring and reviewing of CMC and Device regulatory documents
- Provide direction on content and storyline of the CMC and Device sections of submissions and authority question/answers
- Project management/coordination of technical writing and reviewing activities between internal CMC and Device teams and CMOs/CROs
- Ensure that the documentation is of high quality and that potential issues are discussed with internal and external partners in a timely manner
- Support regulatory in ensure compliance with current and emerging regulations, guidance documents and industry standards.
What we offer
- A relevant academic degree – preferably a Master of Science within Chemistry, Biochemistry, Pharmaceutical sciences, Engineering or similar
- At least 5 years experience from the Pharmaceutical Industry, preferably within drug development and collaboration with CROs/CMOs
- Experience with regulatory requirements for late stage CMC and Device development and with content of regulatory submissions (NDA/BLA/MAA), clinical trial applications and authority meeting packages.
- Hands-on technical writing experience from major regulatory submissions, from a similar position or as medical writer
- Strong written and oral communication skills to summarize studies and a demonstrated ability to convey information in a clear and concise manner
- Proficiency in English at a professional level, both written and spoken
- Strong skills in MS Office, especially in MS Word
- A well-organized working style, delivering high-quality and with attention to detail
- Passion about working in collaborative, complex and fast-paced environment with a high sense of urgency and with the ability to “walk the extra mile”
Zealand’s employees are one of the company’s most important assets, and we strive to attract, develop and retain the best talents, and to be a company where employees thrive.
At Zealand, we understand the value of a diverse workforce, and as an employee you will be part of an innovative cross-disciplinary and cross-cultural working environment. You will be involved in activities that are central to Zealand’s strategy of advancing an exciting product pipeline. You will work together with highly skilled and engaged colleagues in an both ambitious and fun athmosphere.
We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please send your resume/CV and cover letter no later than January 5, 2020.
For further information please contact Vice President of Device & Manufacturing Science at email@example.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.
Zealand is based in Copenhagen (Søborg), Denmark. For further information about the company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.