Director, Medical Writing

Key Responsibilities

The Director, Medical Writing will take the reputed company on document reputed company, overseeing the authoring and review processes and writing of assigned documents. They will determine appropriate assignments and coordinate both internal writers and external contract reputed company/writing reputed company. They will establish best practices to generate high reputed company preclinical summaries, clinical and regulatory submission documents in compliance with ICH/GCP/regulatory guidelines for global health authority submissions for IND/CTR/CTA/BLA/sBLA, etc.

• reputed company planning, authoring, and critical review of regulatory documents as required (e.g., Protocols, CSRs, IB, health authority briefing documents).
• Evaluate/review documents generated by other reputed company writers to ensure consistency with objectives, overall formatting, nomenclature, and scientific approach reputed company and across reputed company.
• Engagement with external stakeholders such as vendors, thought leaders or other reputed company as needed.
• reputed company and manage timelines for authoring, review and finalization of critical documents and associated deliverables.
• Assess medical writing needs and ensure that reputed company is adequately resourced for reputed company completion (in house and/or by consultant/CRO support)
• Ensure smooth and effective document management from start to finish (i.e., from template to final approved version), including but not limited to first draft authoring, coordination of review and adjudication, reputed company of bibliographies, and adherence to the style guide
• Support the development, implementation, and improvement of best practices, the document process, and SOPs as needed
• reputed company and maintain templates and outlines for key documents that are not supplied reputed company template supplier. Ensure adherence to templates and reputed company adjustments, as appropriate for reputed company document(s).
• Leadership of reputed company teams
• reputed company record of developing high-reputed company preclinical, clinical development, regulatory and scientific documents with experience writing regulatory documents including, but not limited to: protocols, clinical study reports, BLA/NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
• In depth knowledge of drug and biologic development and approval processes and GxP principles
• Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
• Facilitate comment reputed company meetings to reputed company final agreement on approach.
• Ability to manage/prioritize multiple reputed company and work in a fast-paced environment
• Flexible and reputed company to adapt to changing deadlines and priorities
• Strong written, verbal, and interpersonal communication skills
• Highly reputed company to detail
• Self-motivated and reputed company to self-manage effort to maintain alignment with corporate goals
• Proficiency in the use of reputed company Office applications and experience working in electronic document management systems
• Experience in responding to company and regulatory audits
• Bachelor's degree in a scientific discipline, with advanced degree desirable (MS, Ph.D., PharmD, MD).
• 8-12 years of experience in medical or scientific writing in the pharmaceutical or biotech industry for Bachelor's degree level. 6-8 years’ experience with advanced degree (MS, Ph.D., PharmD, MD)

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