Submission Manager (m/f)

REFERENZNUMMER:

364107/11

IHRE AUFGABEN:

-Edit complex, often lengthy technical documents for clarity, grammar, spelling, and punctuation; for adherence to applicable regulatory (e.g., CTD) and company’s guidelines; and for consistency within the dossier
-Apply document styles using customized Word templates
-Coordinate the flow of documents via document-sharing systems (e.g., SharePoint)
-Version control throughout the submission generation process (writing, review, and internal approval)
-Support product managers in generating submission timelines; plan and track submission generation activities (e.g., Excel); and evaluate submission-support strategies
-Communicate with technical subject-matter experts to ensure that content is delivered according to schedule and to provide status updates; coordinate and provide training on documentation systems and tools; and collect relevant submission related data
-Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders’ decisions

IHRE QUALIFIKATIONEN:

-Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a related field
-Strong track record as an editor, including at profound professional editing experience, preferably in a scientific or technical field
-Previous experience with regulatory documents (e.g., in CTD structure and other ICH, FDA, and EMA guidelines) and global submission dossiers or in the biotech or pharmaceutical industry is beneficial
-Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style
-Ability to communicate clearly and professionally, both orally and in writing, both in English and in German
-Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.g., Documentum) and document sharing systems (e.g., SharePoint)

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager