Principal Medical Writer

2+ years

Not Disclosed

Remote, USA

10 Nov. 8, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About ICON plc

ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. We are committed to transforming clinical development and improving patient outcomes globally. At ICON, we foster an environment of innovation and professional growth, making it an ideal place for talented individuals to build a rewarding career.

Role Overview

As a Principal Medical Writer, you will be at the forefront of shaping regulatory submissions and critical documents for one of ICON's pharmaceutical clients with a global presence. This unique partnership offers an evolving work environment that mirrors our commitment to career development and continuous learning. You will guide the preparation of medical writing documents, manage regulatory submissions, and ensure content consistency, all while leading writing strategy and collaborating across teams.

Key Responsibilities

Document Preparation & Coordination:
- Oversee the preparation of key medical writing documents, including clinical study reports (CSRs), investigator brochures (IBs), protocols, and regulatory response documents.
- Coordinate writing assignments to teams of writers and lead substantive editing and review of documents to ensure regulatory compliance and high-quality standards.
Writing Strategy & Leadership:
- Lead the writing strategy for regulatory submissions, including developing timelines, formulating writing approaches, and determining resource requirements for documents and submissions.
- Provide expertise in content, organization, and formatting of documents, ensuring alignment with international regulatory guidelines (e.g., ICH, CTD).
Regulatory Submissions:
- Serve as the primary lead writer for important regulatory response documents and key components of major regulatory submissions.
- Ensure consistency of content across therapeutic areas and adherence to Sponsor requirements and regulatory processes across development programs.
Cross-Functional Collaboration:
- Act as a key medical point of contact for clinical regulatory strategy.
- Collaborate with cross-functional teams (e.g., clinical, regulatory affairs) to address issues related to document preparation, timelines, and submission readiness.
Leadership & Mentoring:
- Provide guidance on complex document preparation tasks and lead efforts to resolve issues.
- Mentor junior medical writers, promoting professional development and fostering best practices within the medical writing team.

What You’ll Bring

Qualifications:
- Bachelor’s degree in a scientific or health-related field (e.g., Biology, Pharmacy, Life Sciences).
- 7+ years of experience in medical writing within the pharmaceutical or biotechnology industry.
- At least 3 years of experience writing and preparing electronic documents for major regulatory submissions (e.g., INDs, NDAs, CTDs).
Experience:
- Proven experience as lead writer for key regulatory submission documents (e.g., clinical study reports, protocols, IBs).
- Strong understanding of clinical development, from protocol design to regulatory submission and post-marketing support.
Skills & Knowledge:
- In-depth knowledge of international regulatory requirements and ICH guidelines for document preparation and submissions.
- Strong communication and problem-solving skills, with the ability to interact effectively within and across teams.
- Experience managing writing activities for major international regulatory submissions is preferred.

Why ICON?

At ICON, our success depends on the quality of our people. That’s why we’ve built a culture that rewards high performance, fosters innovation, and nurtures talent. In addition to a competitive salary, we offer:

Comprehensive employee benefits including health insurance, retirement planning, and life assurance.
A Global Employee Assistance Program offering 24-hour support from a network of specialists.
Flexible country-specific benefits, such as childcare vouchers, subsidized travel passes, discounted gym memberships, and health assessments.
A commitment to work-life balance, offering various annual leave entitlements and flexible work options.

Diversity & Inclusion

At ICON, diversity, inclusion, and belonging are at the heart of our culture. We embrace a diverse workforce that helps us innovate and deliver better outcomes for our clients and patients. ICON is an equal opportunity employer, committed to providing a workplace free from discrimination. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Accommodations

If you require reasonable accommodations due to a medical condition or disability to participate in the application process or perform the essential functions of the job, please submit your request here.

Interested in the Role?

Not sure if you meet all the qualifications? Apply anyway! We encourage all talented individuals to apply, and you might be exactly what we’re looking for.

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Principal Medical Writer

Job Description

About ICON plc

Role Overview

Key Responsibilities

What You’ll Bring

Why ICON?

Diversity & Inclusion

Accommodations

Interested in the Role?

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