IQVIA

Principal Medical Writier

IQVIA • $84K — $211K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific, clinical, or regulatory field required; advanced degree preferred
  • 7+ years of medical writing experience in biopharmaceutical, biotechnology, or CRO settings
  • Strong knowledge of global regulatory requirements (ICH, FDA, EMA)
  • Broad understanding of clinical research processes including study design and data analysis
  • Proven ability to lead complex writing activities and offer strategic insights
  • Excellent communication skills for presenting scientific and clinical information
  • Strong organizational and project management skills, capable of managing multiple priorities

Responsibilities

  • Lead the creation of clinical and regulatory documents like Investigator's Brochures and Clinical Study Reports
  • Serve as the lead writer for significant summary documents, overseeing writing across multiple projects
  • Provide strategic guidance on document messaging and regulatory positioning to achieve program goals
  • Manage medical writing projects to meet timelines and submission deadlines
  • Collaborate with cross-functional teams to present clinical data accurately
  • Mentor junior medical writers, ensuring consistent quality across deliverables
  • Review project-related documents for accuracy and compliance while improving best practices

Benefits

  • Opportunities for mentorship and career development
  • Collaborative working environment in a cross-functional team
  • Exposure to various therapeutic areas and regulatory processes
  • Engagement in process improvement initiatives to enhance writing efficiency
  • Access to the latest trends and updates in global regulations
Full Job Description
Overview

We are seeking an experienced PrincipalMedical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and Module II summaries that are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.

The successful candidate will act as a lead writer for key summary documents, providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above).

Key Responsibilities
  • Lead the development of high-quality clinical and regulatory documents (e.g., Investigator's Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards
  • Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs
  • Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals
  • Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met
  • Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data
  • Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects
  • Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides
  • Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements
  • Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation
  • Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing
  • Stay current with evolving global regulatory requirements, industry trends, and therapeutic area knowledge to ensure compliance and innovation


Qualifications
  • Bachelor's degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
  • Minimum of 7+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
  • Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
  • Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
  • Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
  • Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
  • Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
  • Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
  • High attention to detail with a commitment to quality, consistency, and scientific accuracy
  • Proficiency in Microsoft Word and document formatting best practices


The potential base pay range for this role, when annualized, is $84,400.00 - $211,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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