Expert Regulatory Writer

Major accountabilities:

• To author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
• Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
• Ad-hoc member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT).
• Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
• Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD.
• Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents.
• Lead process improvement in RWS and cross-functional initiatives and/or activities.
• Can identify training needs to foster high level of performance within RWS. Coach and/or mentor less experienced writers.
• Leader in cross-functional communication to optimize feedback and input towards high quality documents.
• Maintain audit, SOP and training compliance.

Key performance indicators:

• Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards, according to RWS metrics.
• Completion of an adequate volume of work (taking into account complexity) per year in accordance with the Key Performance Indicators.

Minimum Requirements:
Work Experience:

• ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes.
• Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs.
• Excellent communication skills (written, verbal, presentations) • Expert knowledge of biostatistics principles.
• Proven ability to prioritize and manage multiple demands and projects.
• Demonstrated ability to define and solve complex problems (“Problem-solver”)
• Broad knowledge and future oriented perspective
• Proven ability to drive and manage organizational and team performance across cultures.
• Proven track record in matrix environment
• Repeat experience in managing global, cross-functional teams or complex global projects.
• Demonstrated ability to motivate and coach people.