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Senior Director Medical Writing

Plano, TX, USA | Planet Pharma

  • Industry:
    HR / Recruitment Services
  • Position Type:
    Full-Time
  • Functions:
    General Management
  • Experience:
    7-10 years
Job Description:
88 people have viewed this job

Summary:


The Senior Director, Medical Writing will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs); manage external and internal communications regarding key clinical development activities.


Responsibilities


• Assure efficient completion of high quality and on-time writing deliverables through effective planning and management of medical writing resources. When necessary, write or QC documents or lead document review meetings, to deliver high-quality documents on-time.


• Work with project management and team members to develop and align on document writing timelines and review cycles


• Assure that writing projects are adequately staffed. Manage contract and employee medical writing resources, assuring on time delivery of high quality written documents. Facilitate efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.


• If/when needed, plan, write, edit, and format key documents with minimal supervision, including clinical protocols, investigator brochures, clinical study reports, pharmacy and other manuals, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.


• Represent Medical Writing on project teams.


• Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.


• Serve as subject matter expert for clinical documents and their production.


• Lead SOP and template development and maintenance for medical writing documents.


• Manage external and internal communications regarding key clinical development activities, including important safety events, changes to development programs, etc that require broad internal and external communications. Assure an agreed communication plan is in place and that plan is executed upon in a timely way.


Qualifications


• Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree (M.S./Ph.D.) and/or professional certification/credentials strongly preferred.


• 4+ years of experience as a medical writer in the sponsor and/or CRO setting for applicants with a Masters or higher degree. 7+ years of experience as a medical writer in the sponsor and/or CRO setting for applicants with a Bachelors degree. Experience with regulatory submissions (CTA/IND/NDA/BLA) required. Knowledge of eCTD formatting is a plus.


• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.


• Successful track record of managing people and multiple projects in a fast-paced and deadline-driven environment.


• Impeccable attention to detail and ability to assure completion or complete writing assignments in a timely manner with minimal oversight.


• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint. 


Requirements:

Qualifications


• Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree (M.S./Ph.D.) and/or professional certification/credentials strongly preferred.


• 4+ years of experience as a medical writer in the sponsor and/or CRO setting for applicants with a Masters or higher degree. 7+ years of experience as a medical writer in the sponsor and/or CRO setting for applicants with a Bachelors degree. Experience with regulatory submissions (CTA/IND/NDA/BLA) required. Knowledge of eCTD formatting is a plus.


• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.


• Successful track record of managing people and multiple projects in a fast-paced and deadline-driven environment.


• Impeccable attention to detail and ability to assure completion or complete writing assignments in a timely manner with minimal oversight.


• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint


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