Medical Writer - Regulatory Submissions - Nationwide

Cardinal Health, Inc.; Massachusetts; Remote; USD 93,000 - 137,000; Full time

Job summary

An established industry player is seeking a Regulatory Technical Writer to join their dynamic team. This role is crucial in supporting the Global Regulatory Affairs department, focusing on the development of high-quality regulatory documents for submissions to health authorities. You will leverage your scientific writing expertise and analytical skills to communicate complex data effectively. This innovative firm values diversity and promotes an inclusive workplace, offering a comprehensive benefits package and opportunities for professional growth. If you're passionate about making a difference in the healthcare field, this is the perfect opportunity for you.

Benefits

Medical coverage

Dental coverage

Vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Paid parental leave

Healthy lifestyle programs

Qualifications

• 4-8 years of experience in medical writing or regulatory affairs.
• Excellent scientific writing and analytical skills are essential.

Responsibilities

• Prepare and review regulatory documents for submission to agencies.
• Collaborate with teams to advance regulatory programs and projects.

Skills

Scientific writing

Analytical thinking

Data extraction and analysis

Communication skills

Teamwork

Proactive attitude

Education

Bachelor's degree in a related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

What Medical Writing brings to Cardinal Health:

Full-service product development and regulatory affairs consulting team that enables pharmaceutical, medical, and biotechnology companies to 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 organizational objectives.

• Completes work independently; receives general guidance on new projects. Work is reviewed for the purpose of meeting objectives. May act as a 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 the 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 the scope and direction of data-driven summaries.

Responsibilities

• Prepare, write, edit, and review high-quality regulatory documents founded in regulation and supported by science for submission to regulatory agencies and health authorities. This includes but is 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, and 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 and 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 and provide guidance 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 a 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:

• Bachelor's degree preferred or equivalent experience in a related field.

• 4-8 years of experience preferred.

• Excellent scientific writing skills.

• Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical, or Regulatory role.

• Advanced knowledge of ISO 13485, 21 CFR 820, EU MDD, EU MDR, FDA guidance documents, and MEDDEV requirements.

• Experience performing literature searches in Embase, PubMed, and Google Scholar, analyzing data, and communicating outputs.

• Experience using Microsoft Word, Excel, and PowerPoint. Strong data extraction and analysis skills.

• 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, and flexibility.

• 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 - $136,600

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 payday 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: 2/28/2025 *if interested in the opportunity, please submit your 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

#LI-remote

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.