Principal Medical Writer at ICON Strategic Solutions

Feedinkoo; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Principal Medical Writer to join their dynamic team. In this pivotal role, you will independently author crucial clinical documents and ensure compliance with regulatory standards, all while mentoring junior writers. This position offers an exciting opportunity to impact clinical development and contribute to innovative healthcare solutions. With a commitment to diversity and employee well-being, the company provides a supportive environment that values high performance and nurtures talent. If you are passionate about making a difference in the pharmaceutical field, this could be the perfect opportunity for you.

Benefits

Health Insurance

Annual Leave Entitlements

Retirement Planning

Employee Assistance Programme

Life Assurance

Flexible Optional Benefits

Qualifications

• 6+ years in the pharmaceutical industry with a focus on regulatory writing.
• Experience in writing submission documents, especially in oncology.

Responsibilities

• Authors study level documents and validates study protocol designs.
• Mentors junior writers and contributes to data presentation standards.

Skills

Regulatory Medical Writing

Clinical Research

Data Presentation Strategy

Mentoring

Education

Master’s degree in Life Sciences

PhD in Life Sciences

Bachelor’s degree in Life Sciences

Job description

Principal Medical Writer at ICON Strategic Solutions

As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Principal Medical Writer independently authors study level documents (collaborating with the team), implements project level data presentation and messaging standards for assigned documents, validates individual study protocol design and clinical study report (CSR) key messages based on the strategy provided.

What You Will Be Doing

1. Drives the design of all assigned project level submission documents in support of the Clinical Development Plan (CDP).
2. Validates the individual study protocol design and clinical study report (CSR) key messages.
3. Contributes to the project level data presentation strategy and messaging standards.
4. Authors other clinical regulatory documents, as required such as IND, NDA/MAA/BLA, Clinical Overviews, Clinical Summary of efficacy & Integrated summary of efficacy, Clinical Summary of Safety.
5. Mentors Senior Scientific Medical Writers and Scientific Medical Writers in developing expertise in writing clinical, regulatory and submission documents.

You Are

1. A Master’s degree in the life sciences and a minimum of 6 years experience in the pharmaceutical industry or a PhD in the life sciences and a minimum of 4 years experience in the pharmaceutical industry is strongly preferred.
2. Highly qualified candidates with a Bachelor’s degree may be considered.
3. In all cases, the candidate should have at least 5 years experience in regulatory medical writing, 3 of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.), preferably in the area of oncology.

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

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

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.