Biogen

Content Writer

• Write and/or manage complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development
• Provide direct supervision for Medical Writing program leads and mentor junior writers
• Respond to Medical Writing issues with internal cross-functional teams and external development partners
• Contribute to long-term growth strategy of the department and ensure SOPs are followed across projects
• Synchronize prioritization of projects and represent Medical Writing in meetings with governance committees, regulatory agencies, and external development partners
• Perform outreach within pharmaceutical/biotech industry to maintain knowledge of evolving industry standards and establish best practices
• Prepare clinical and regulatory documents and packages: protocols and amendments, CSRs, IBs, INDs/CTAs, submissions
• Lead planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements
• Support development and maintenance of SOPs and templates for document development
• Critically analyze and synthesize complex scientific information to ensure scientific accuracy and consistency of documents
• Develop and integrate messaging and medical writing strategy to ensure consistency through documents in a therapeutic area
• Collaborate with cross-functional SMEs including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations
• Participate in regulatory submission planning, timelines, and document development
• Manage and/or provide oversight of in-house and/or contractor/vendor medical writers, ensuring high-quality deliverables
• Review statistical analysis plans and clinical data reports incorporated in data-related documents and provide strategic input to TFL outputs
• Lead departmental initiatives as necessary

Director, Medical Writing

Director

• Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) Provide functional representation on development program s and study teams and identify opportunities where modeling and simulation can ad vance the understanding of pharmacological activity, efficacy and safety Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results Conduct hands - o n quantitative ana lysis and present the findings to multidisciplinary project teams Serve as lead author and key contributor to clinical pharmacology sections of documents Serve as the subject matter expert in interactions with Health Authorities Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology , and drug development precedent ​

Director, Medical Writing

Associate Scientific Director, Clinical Pharmacology