IQVIA

Senior Medical Writer

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

Qualifications

  • Bachelor's Degree in life sciences or related field; Master's or Ph.D. preferred
  • 5+ years of relevant medical writing experience
  • Proficient in structuring clinical study reports and protocols
  • Strong understanding of statistical methods in clinical trials
  • Excellent written and oral communication skills
  • Ability to identify inconsistencies in scientific documents
  • Demonstrated leadership in mentoring and training junior staff

Responsibilities

  • Lead document preparation and ensure compliance with SOPs
  • Plan, organize, and manage multiple writing projects
  • Facilitate and lead meetings on complex topics
  • Train and mentor junior medical writers
  • Deliver presentations on medical writing processes
  • Manage budgeting and financial forecasting for projects
  • Coordinate communication and negotiations with customers

Benefits

  • Training and development opportunities
  • Mentorship programs
  • Cross-functional collaboration
  • Exposure to diverse therapeutic areas
  • Opportunity to influence project direction
Full Job Description
Job Overview:
Acts as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. Provides written and verbal feedback to junior staff, and to customers when appropriate. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Essential Functions:
  • Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
  • Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
  • Lead meetings on more challenging topics independently.
  • May present on standard Medical Writing processes at full-service bid defense meetings.
  • Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others.
  • May develop and deliver training to the global team on a topic he/she has specific expertise in.
  • May input into and deliver presentations on Medical Writing to other IQVIA groups.
  • May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
  • Complete project finance activities, including monitoring and forecasting budgeted hours.
  • Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.
  • May take on a small customer lead role or assist an established partnership lead in their role.
  • May represent region or site on a Medical Writing initiative or cross-functional initiative.
  • Facilitates and brainstorms the identification of new ideas.
  • May represent Medical Writing at a general capabilities audit.


Qualifications:
  • Bachelor's Degree in life sciences related discipline or related field
  • Master's Degree of Ph.D in life sciences related discipline or related field is preferred
  • Typically requires at least 5 years of highly relevant experience and related competency levels.
  • In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
  • Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
  • Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
  • Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
  • Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
  • In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
  • Excellent written and oral communication skills including grammatical/technical writing skills.
  • Excellent attention to detail and accuracy.
  • Confident and effective communication and negotiation skills with customers and project managers.
  • Able to deliver difficult messages in constructive manner.
  • Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
  • Demonstrated abilities in collaboration with others and independent thought.
  • Demonstrates confidence and maturity in most routine medical writing situations.
  • Demonstrates good judgement in requesting input from senior staff.
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers.
  • Ability to effectively manage multiple tasks and projects.
  • Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
  • Must be computer literate.


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.

Keep Up to Date

Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at IQVIA

More Pharmaceuticals & Biotech Jobs

Find similar Senior Medical Writer jobs:

NationwideDurham, NC