Senior Manager/Associate Director, Medical Writer
Remote
Full Time
Mid Level
Position Overview:
As a Sr. Manager/AD, Medical Writer you will be responsible for document creation across clinical development and medical affairs. It is expected this will include the successful preparation of high quality, submission-ready regulatory documents, reports and protocols through implementation of the regulatory medical writing process in collaboration with cross-functional study teams. Your collaboration with the medical affairs team on publication strategy and execution, in alignment with applicable guidelines, will allow exemplary external representation of Abeona and its products.
Essential Duties & Responsibilities:
Typical duties would include:
As a Sr. Manager/AD, Medical Writer you will be responsible for document creation across clinical development and medical affairs. It is expected this will include the successful preparation of high quality, submission-ready regulatory documents, reports and protocols through implementation of the regulatory medical writing process in collaboration with cross-functional study teams. Your collaboration with the medical affairs team on publication strategy and execution, in alignment with applicable guidelines, will allow exemplary external representation of Abeona and its products.
Essential Duties & Responsibilities:
Typical duties would include:
- Substantive preparation, editing, and review of regulatory and/or clinical documents, independent preparation of medical writing deliverables as needed, and coordinating the writing and documentation of key preclinical and clinical scientific data through peer-reviewed journals and forums
- Independently prepares clinical development related documents, including protocols and clinical study reports in collaboration with coordination of review and input from multiple functional area teams in support of various investigational compounds' clinical development
- Independently prepares preclinical documents and study reports in collaboration with the cross-functional team.
- Independently prepares and edits multiple investigational compounds' safety and efficacy summary documents, Investigator's Brochures (IBs), IB addendums, package inserts, study protocol amendments, clinical modules for Investigational New Drug applications (INDs), documents to support formal meetings between the FDA and Sponsors or Applicants (eg, Briefing Books), and other documents that may be submitted to the FDA and/or the EMEA for publication and/or presentation. Additionally, is able to lead and edit writing of the modules of a BLA submission.
- Responsible for identifying medical writing resourcing needs while also functioning as an individual contributor driving, developing and writing documents to support operational, medical and regulatory activities across projects
- Ensure scientifically robust messages and arguments are developed and conveyed consistency across documents
- Collaboratively contributes to regulatory medical writing tasks across functional teams and projects
- May assist in the development of regulatory document templates, formatting, and guidelines for clinical documentation
- May prepare scientific abstracts and manuscripts
- Proactively keeps abreast of professional information, trends and technology through conferences, networking and other information sources and brings forward innovative ideas for consideration
- Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and nonclinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences
- Perform other duties as assigned
Qualifications:
• Bachelor’s degree required/ Masters or PhD preferred, preferably in a related scientific discipline
• Minimum of 3+ years of pharmaceutical regulatory medical writing and 3+ years of scientific/academic writing experience, and ability to provide samples of both pharmaceutical and scientific writing experience.
• An agile, fast learner who has working knowledge of processes and SOPs
• Outstanding interpersonal, written and oral communication skills, an ability to work in collaboration with a cross-functional study team, able to establish rapport with all functional leaders, experts and colleagues
• Ability to multitask while driving towards critical deadlines on all projects
• Superior attention to detail; ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy in US- and UK-based English
• Superior computer skills; experienced with MS Office (Word, Excel, PowerPoint, Outlook) and database applications. Preferably familiar with current electronic authoring, document management, and electronic regulatory submissions.
• Bachelor’s degree required/ Masters or PhD preferred, preferably in a related scientific discipline
• Minimum of 3+ years of pharmaceutical regulatory medical writing and 3+ years of scientific/academic writing experience, and ability to provide samples of both pharmaceutical and scientific writing experience.
• An agile, fast learner who has working knowledge of processes and SOPs
• Outstanding interpersonal, written and oral communication skills, an ability to work in collaboration with a cross-functional study team, able to establish rapport with all functional leaders, experts and colleagues
• Ability to multitask while driving towards critical deadlines on all projects
• Superior attention to detail; ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy in US- and UK-based English
• Superior computer skills; experienced with MS Office (Word, Excel, PowerPoint, Outlook) and database applications. Preferably familiar with current electronic authoring, document management, and electronic regulatory submissions.
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