What Medical Writing and Product Development (Regulatory) contribute to Cardinal Health
For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle to help ensure the continued success of your product post-approval.
Sr. Medical Writers within our Specialty Solutions business at Cardinal Health summarize data into concise and accurate reports in formats that comply with regulatory agency requirements and client expectations. In addition, these individuals author all types of regulatory and non‑regulatory documents, including CTD/eCTD summary documents, clinical study reports, patient narratives, clinical study protocols, manuscripts, Investigator Brochures, and briefing books, among others.
Location - Fully remote (work hours will be 8am - 5pm in whatever time zone the individual resides)
Responsibilities
- Compile, write, and edit regulatory documents and reports, including clinical study protocols, CSRs, IBs, safety narratives, safety reports, information packages, publications, ISS, ISE, and sections of CTD/eCTD summary documents (INDs, NDAs, BLAs, MAAs, Amendments, and Annual Reports) 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 heath authority questions and requests.
- Willingness to 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; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance.
Qualifications
- PhD, PharmD, MS, RN, BS, or RPh in a relevant scientific or pharmaceutical discipline, preferred.
- Ideally targeting 5+ years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry (preferred).
- Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, Clinical Study Reports (CSR), Investigator’s Brochure (IB), clinical sections of Investigational Medicinal Product Dossier and Common Technical Document (IMPD and CTD/eCTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines (required).
- Excellent oral (including presentation) and written communication, and project management skills.
- Awareness of pharmaceutical industry needs beyond clinical development.
- 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, 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 and concepts of structured content management.
- Skillsets required include demonstrated leadership capabilities, team player mentality, excellent communication, strong project management skills, organized and self-motivated, strong attention to detail.
What is expected of you and others at this level
- Participates in the development of policies and procedures to achieve specific goals
- Recommends new practices, processes, metrics, or models
- Works on or may lead complex projects of large scope
- Provides solutions which may set precedent
- Independently determines method for completion of new projects
- Receives guidance on overall project objectives
- Acts as a mentor to less experienced colleagues
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Anticipated Pay Range $121,600.00 - 173,650.00 USD
Bonus Eligible - Yes
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
- 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
Application window anticipated to close: 12/15/2024 * if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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