Sr. Scientist, Medical Writing and Product Development
About the position
The Sr. Scientist in Medical Writing and Product Development at Cardinal Health plays a crucial role in summarizing data into regulatory documents and reports that comply with agency requirements and client expectations. This position involves authoring various regulatory and non-regulatory documents, ensuring the successful navigation of products through the regulatory landscape, and contributing to the overall success of pharmaceutical and biotechnology products post-approval.
Responsibilities
• Compile, write, and edit regulatory documents and reports, including clinical study protocols, CSRs, IBs, safety narratives, and sections of CTD/eCTD summary documents across multiple therapeutic areas.
,
• Interpret data, analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
,
• Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
,
• Manage and direct client project teams, including identifying, directing, and delegating tasks necessary for successful document completion.
,
• Interact directly with clients and contractors; participate in and lead discussions during meetings.
,
• Collaborate with project teams to respond to health authority questions and requests.
,
• Mentor and help other medical writers in the writing, editing, and compilation of documents.
,
• Prepare and manage project plans and timelines.
,
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
,
• Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously and reorganize and reschedule work as needed in order to meet client deadlines.
,
• Understand and support the nature of our business and our company's commitment to quality and responsiveness.
,
• Proactively develop/maintain technical knowledge, remain up to date on current trends and best practices.
Requirements
• PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline, preferred.
,
• 5+ years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry, preferred.
,
• Ability to prepare any type of clinical regulatory document without supervision according to company guidelines and international governmental regulations.
,
• Excellent oral and written communication, and project management skills.
,
• Strong understanding of drug development, clinical study design, regulations (CFR, FDA, and ICH guidelines), and scientific principles.
,
• Understanding of medical terminology and statistical methodology is a must.
,
• Experience writing clinical protocols, clinical study reports, and CTD/eCTD summaries.
,
• Strong command of English language, grammar, style, and logical progression.
,
• Ability to write in a clear and concise manner, as well as edit on all levels, from copy editing to major rewriting.
,
• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint.
Nice-to-haves
• Demonstrated leadership capabilities
,
• Team player mentality
,
• Strong attention to detail
Benefits
• Medical, dental and vision coverage
,
• Paid time off plan
,
• Health savings account (HSA)
,
• 401k savings plan
,
• Access to wages before pay day with myFlexPay
,
• Flexible spending accounts (FSAs)
,
• Short- and long-term disability coverage
,
• Work-Life resources
,
• Paid parental leave
,
• Healthy lifestyle programs
Apply Now
The Sr. Scientist in Medical Writing and Product Development at Cardinal Health plays a crucial role in summarizing data into regulatory documents and reports that comply with agency requirements and client expectations. This position involves authoring various regulatory and non-regulatory documents, ensuring the successful navigation of products through the regulatory landscape, and contributing to the overall success of pharmaceutical and biotechnology products post-approval.
Responsibilities
• Compile, write, and edit regulatory documents and reports, including clinical study protocols, CSRs, IBs, safety narratives, and sections of CTD/eCTD summary documents across multiple therapeutic areas.
,
• Interpret data, analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
,
• Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
,
• Manage and direct client project teams, including identifying, directing, and delegating tasks necessary for successful document completion.
,
• Interact directly with clients and contractors; participate in and lead discussions during meetings.
,
• Collaborate with project teams to respond to health authority questions and requests.
,
• Mentor and help other medical writers in the writing, editing, and compilation of documents.
,
• Prepare and manage project plans and timelines.
,
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
,
• Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously and reorganize and reschedule work as needed in order to meet client deadlines.
,
• Understand and support the nature of our business and our company's commitment to quality and responsiveness.
,
• Proactively develop/maintain technical knowledge, remain up to date on current trends and best practices.
Requirements
• PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline, preferred.
,
• 5+ years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry, preferred.
,
• Ability to prepare any type of clinical regulatory document without supervision according to company guidelines and international governmental regulations.
,
• Excellent oral and written communication, and project management skills.
,
• Strong understanding of drug development, clinical study design, regulations (CFR, FDA, and ICH guidelines), and scientific principles.
,
• Understanding of medical terminology and statistical methodology is a must.
,
• Experience writing clinical protocols, clinical study reports, and CTD/eCTD summaries.
,
• Strong command of English language, grammar, style, and logical progression.
,
• Ability to write in a clear and concise manner, as well as edit on all levels, from copy editing to major rewriting.
,
• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint.
Nice-to-haves
• Demonstrated leadership capabilities
,
• Team player mentality
,
• Strong attention to detail
Benefits
• Medical, dental and vision coverage
,
• Paid time off plan
,
• Health savings account (HSA)
,
• 401k savings plan
,
• Access to wages before pay day with myFlexPay
,
• Flexible spending accounts (FSAs)
,
• Short- and long-term disability coverage
,
• Work-Life resources
,
• Paid parental leave
,
• Healthy lifestyle programs
Apply Now