Tasks:

Convert scientific data into clear, scientifically sound, well-structured scientific, clinical, and regulatory documents intended for global health authorities is essential.
Support writing efforts for on Company’s MAA submission packages
Collaborate on development of clinical study documents (e.g. clinical study reports, bioanalytical methods reports), in accordance with applicable regulations
Liaison with biomarker and immune-monitoring department for bioanalytical technical reports
Liaison with CRO medical writer delegates for clinical documents
Participate in/lead comment resolution meetings, as applicable
Performing a quality control (QC) check of written documents
Participate in teams meeting as applicable
Complete other responsibilities as assigned and agreed upon

Qualification:

Start: asap, latest 15.01.2021 // Duration: 6 months // Capacity: full-time
Minimum of BS/BA degree in science (Masters, PhD, or PharmD preferred) with at least 5 years of relevant regulatory writing experience in the pharmaceutical and biotechnology industry
Strong understanding of bioanalytical methods, immune-monitoring, biomarker and pharmacodynamics
Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
Knowledgeable of GCP, GXP requirements and FDA/EMA guidelines
Excellent writing and organizational skills, and an ability to generate clear, concise documents
Proficiency using Microsoft Word, Excel, and PowerPoint
Excellent writing ability with strong editorial and formatting skills
Fluency in written and spoken English
An independently motivated working style with good problem-solving skills allowing analysis, synthesis, and compilation of data from a broad range of disciplines
A demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
An ability to work in a fast-paced, cohesive, collaborative team-oriented work environment
Certification in medical writing and/or Medical Writer Certified preferred
Nice to have: German