These job descriptions are examples. Looking for work?

Find JobsFind Jobs

Health Care - Medical Writer

0 people like this description

Ensuring the timely and correct creation of clinical study reports for Phase 1/2a studies as well as of project and submission documents in cooperation with the Clinical Sciences' project leaders and study managers in accordance to the agreed submission relevant project-/study goals and abiding by all international and regulatory standards

• Manages the planning, creation, review and approval of the clinical study report according the valid SOPs in order to ensure the completion of high quality documents
• Independently creates draft clinical study reports for Phase 1 and 2 a studies based on all available study documentation (e.g. statistical table sets, reference documents, subject data listings, etc.)
• Independently creates draft project or submission documents (or parts thereof) in close cooperation with the CS project responsible persons (Clinical Pharmacology Leader, CPL or Early Pharmacology Leader, ECL)
• Review of submission-relevant project and study documents for correctness, plausibility and compliance with internal and international standards
• Actively communicate and work with project or study teams as well as other key interface partners to facilitate the completion of clinical study reports and submission documents.
• Support the Global Regulatory Strategist (GRS) and CPL in developing and maintaining all CS submission relevant documents for a particular project, work with the CPL to develop project level standards in line with overall messaging strategy, work with assigned submission team experts (Medical Expert [ME], CPL, GRS) in developing and implementing the submission authoring strategy for all CS sections needed for a submission
• Interacts with the Global Submission Teams to ensure all CTD documents meet all required global, regulatory and quality standards.
• Interacts with contract research organizations (CROs) and individual contract medical writers regarding writing projects that have been contracted outside of Bayer, to ensure the medical writing deliverables meet all Bayer standards.

These job descriptions are examples. Looking for work?

Find JobsFind Jobs