Sr Medical Writer

ICON Strategic Solutions; Brasil; Presencial; BRL 90 000 - 150 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Retirement planning

Employee Assistance

Life assurance

Flexible benefits

Resumo da oferta

ICON plc in Brazil is seeking a Senior Medical Writer to lead medical writing strategies for clinical research projects and contribute to the development of innovative treatments.

You will own the creation and review of core documents such as protocols, CSRs, IBs, and publications, and you will mentor junior writers while collaborating with clinical research, biostatistics, regulatory, and medical affairs teams to ensure high scientific quality and regulatory readiness.

Qualificações

• Bachelor's degree in a relevant scientific field.
• Strong ability to interpret and summarize clinical data and write clearly.
• Knowledge of ICH-GCP, FDA, EMA guidelines and regulatory submissions.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent interpersonal and communication skills for cross-functional collaboration.

Responsabilidades

• Lead the preparation, review, and editing of clinical study documents (Protocols, CSRs, IBs) for regulatory submissions.
• Collaborate with clinical research, biostatistics, regulatory, and medical affairs teams to summarize trial data.
• Plan and provide scientific input for development programs and study design interpretation.
• Develop publication plans, abstracts, posters, and manuscripts for peer-reviewed journals.
• Mentor junior medical writers and promote best practices and continuous learning.

Conhecimentos

Medical writing

Regulatory understanding

Cross-functional collaboration

Editing and proofreading

Independent leadership

Formação académica

Bachelor's degree in a relevant scientific discipline

Ferramentas

MS Word

Descrição da oferta de emprego

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Senior Medical Writer at ICON, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

What You Will Do

You will take ownership of medical writing deliverables, applying your expertise to complex challenges.

Key Responsibilities Include

• Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity
• Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings
• Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
• Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences
• Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

Your Profile

You will have a strong foundation in medical writing, with the experience to work independently and guide others.

Required Qualifications And Experience

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.
• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.