Regulatory Technical Writer - Cardinal Health
Dover, DE
About the Job
_What Medical Writing bring to Cardinal Health:_
Full-service product development and regulatory affairs consulting team that enables pharmaceutical, medical and biotechnology companies obtain regulatory approval.
_What is expected of you and others at this level:_
+ Applies comprehensive knowledge and a thorough understanding of concepts, principles and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures
+ Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
+ Completes work independently; receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as mentor to less experienced colleagues
The Regulatory Technical Writer (RTW) plays an important role in the Regulatory Affairs department supporting regulatory document writing to develop the global evidence base for company development programs. RTW is responsible for providing support to Global Regulatory Affairs (GRA) team for all submission needs. The Writer in this position will develop documents required to facilitate global regulatory programs by incorporating an understanding of the clinical development program, relevant scientific literature, and regulatory goals to drive scope and direction of data-driven summaries.
_Responsibilities_
+ Prepare, write, edit and review high-quality regulatory documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. This includes but not limited to 510(k)s, Pre-Market Approval (PMA) submissions and PMA Supplements, EU Technical Documentation Files and Global STEDs, Pre-Submission meeting packages to agencies, responses to regulatory agency requests, annual reports.
+ Provide support for the preparation and submission of critical regulatory documents and responses to health authority information requests using available reference materials, scientific literature, and content provided by the Global Regulatory Affairs (GRA) team members & functional area contributors.
+ Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
+ Work closely with team members on the strategic content of target documents.
+ Collaborate with project teams and functional area contributors to advance global regulatory programs and product development projects.
+ Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRA team and/or authors/key opinion leaders. Ensure required documentation is obtained.
+ Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
+ Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Resolve document content issues and questions arising during the writing process.
+ Assist in the design and implementation of tactical process improvements.
_Qualifications:_
+ BA, BS or equivalent experience in related field
+ 4-8 years of experience
+ Excellent scientific writing skills
+ Proven experience performing literature reviews, analyzing data and communicating outputs
+ Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
+ Experience writing scientific documents for regulatory or journal submissions
+ Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
+ Demonstrated ability to build positive constructive relationships with cross-functional team members
+ Demonstrated high level of personal integrity, emotional intelligence, flexibility
+ Extensive knowledge of MDD, MDR and MEDDEV requirements
+ Experience creating and performing literature searches in Embase, PubMed and Google Scholar
+ Experience using Microsoft Word, Excel, PowerPoint. Strong data extraction and analysis skills
+ Proactive with a sense of urgency in managing job responsibilities
+ Self-motivated and able to work independently and with a minimum of supervision.
+ Analytical thinking and inquisitive mindset
+ Ability to work in a team environment and desire to develop good working relationships internally and externally
Anticipated salary range : $93,500 - $ 1336,600
Bonus eligible : No
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: 12/27/2024 *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.
#LI-MP1
_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._
_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Full-service product development and regulatory affairs consulting team that enables pharmaceutical, medical and biotechnology companies obtain regulatory approval.
_What is expected of you and others at this level:_
+ Applies comprehensive knowledge and a thorough understanding of concepts, principles and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures
+ Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
+ Completes work independently; receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as mentor to less experienced colleagues
The Regulatory Technical Writer (RTW) plays an important role in the Regulatory Affairs department supporting regulatory document writing to develop the global evidence base for company development programs. RTW is responsible for providing support to Global Regulatory Affairs (GRA) team for all submission needs. The Writer in this position will develop documents required to facilitate global regulatory programs by incorporating an understanding of the clinical development program, relevant scientific literature, and regulatory goals to drive scope and direction of data-driven summaries.
_Responsibilities_
+ Prepare, write, edit and review high-quality regulatory documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. This includes but not limited to 510(k)s, Pre-Market Approval (PMA) submissions and PMA Supplements, EU Technical Documentation Files and Global STEDs, Pre-Submission meeting packages to agencies, responses to regulatory agency requests, annual reports.
+ Provide support for the preparation and submission of critical regulatory documents and responses to health authority information requests using available reference materials, scientific literature, and content provided by the Global Regulatory Affairs (GRA) team members & functional area contributors.
+ Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
+ Work closely with team members on the strategic content of target documents.
+ Collaborate with project teams and functional area contributors to advance global regulatory programs and product development projects.
+ Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRA team and/or authors/key opinion leaders. Ensure required documentation is obtained.
+ Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
+ Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Resolve document content issues and questions arising during the writing process.
+ Assist in the design and implementation of tactical process improvements.
_Qualifications:_
+ BA, BS or equivalent experience in related field
+ 4-8 years of experience
+ Excellent scientific writing skills
+ Proven experience performing literature reviews, analyzing data and communicating outputs
+ Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
+ Experience writing scientific documents for regulatory or journal submissions
+ Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
+ Demonstrated ability to build positive constructive relationships with cross-functional team members
+ Demonstrated high level of personal integrity, emotional intelligence, flexibility
+ Extensive knowledge of MDD, MDR and MEDDEV requirements
+ Experience creating and performing literature searches in Embase, PubMed and Google Scholar
+ Experience using Microsoft Word, Excel, PowerPoint. Strong data extraction and analysis skills
+ Proactive with a sense of urgency in managing job responsibilities
+ Self-motivated and able to work independently and with a minimum of supervision.
+ Analytical thinking and inquisitive mindset
+ Ability to work in a team environment and desire to develop good working relationships internally and externally
Anticipated salary range : $93,500 - $ 1336,600
Bonus eligible : No
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: 12/27/2024 *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.
#LI-MP1
_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._
_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Source : Cardinal Health