Clinical Medical Writer Consultant
Kaztronix —San Diego, CA
- Contract
- Remote
- 8 years
- Bachelor's degree
- Continuous improvement
Quick Apply
6d
Creative Writer – Weekly Blogging Program (Contract)
The Exceptional Plan —Remote
- $27.00 - $32.52 an hour
- Contract
- Remote
- Entry level
- Flexible schedule
Quick Apply
7d
Communication Professionals
Handshake AI —Remote
- Up to $100 an hour
- Part-time
- 5 years
- Research
- Senior level
- Flexible schedule
ELA Assessment Writer-Middle School (NY)
Excellence Community Schools —Remote
- Remote
- English
- Mid-level
- Middle school
Quick Apply
14d
Resume Writer
The Human Reach —Remote
- $0 a year
- Choose your own hours
- Remote
- Writing skills
- Entry level
- Flexible schedule
Quick Apply
Junior Web Content Writer
AutoLoanDaily —Remote
- $30,000 - $35,000 a year
- Full-time
- Computer literacy
- 1 year
- Entry level
Part-Time College Essay Support Specialist
College Planning Source —Remote
- $25 an hour
- Part-time
- Remote
- High school
- 2 years
- Entry level
Quick Apply
Health Writer & Content Creator
Thrive Global Holdings, Inc. —Remote
- $115,000 - $130,000 a year
- Full-time
- Remote
- Mid-level
- 10 years
- Health insurance
- Dental insurance
Quick Apply
7d
Writer I
Red Carrot —Remote
- Full-time
- Remote
- Bachelor of Science
- Public speaking
- English
- Profit sharing
- Paid holidays
Quick Apply
College Admissions Counselor/Consultant
Ingenius Prep —Remote
- $25 - $50 an hour
- Part-time
- Remote
- Research
- Mid-level
- Bachelor's degree
- Flexible schedule
Quick Apply
Article Writers
Dignitas —Remote
- Email
- Remote
- 18 years or older
- English
- Entry level
Content Writer (contract)
Microsoft —Remote
- $29 - $33 an hour
- Contract
- Remote
- Mid-level
- Team management
- US work authorization
- Health savings account
- AD&D insurance
Part-Time Grant Writer Job Description
Health Science Career Pathway Advocates —California
- $37 - $50 an hour
- Temporary
- Remote
- High school
- Research
- Mid-level
Quick Apply
8d
Content Writer
Kaplan —Remote
- Part-time
- Remote
- Background check
- Military
- Computer literacy
- Paid holidays
- Health insurance
Writer, Public Relations & Communications (Remote)
LaunchSquad —San Francisco, CA
- $3,000 - $6,000 a month
- Remote
- Mid-level
- 3 years
- Organizational skills
Quick Apply
Medical Content Specialist (Contract)
Everlywell —Remote
- $45 - $55 an hour
- Part-time
- Remote
- Clinic experience
- Mid-level
- 3 years
Deal Hunter and Content Writer
Brad's Deals —Remote
- $50,000 - $60,000 a year
- Full-time
- Remote
- Mid-level
- Profit sharing
- Health insurance
Marketing Content Writer
EPIC Brokers —Remote
- $90,000 - $110,000 a year
- Hybrid work
- Mid-level
- Continuous improvement
- Communication skills
- Paid parental leave
- Paid holidays
Quick Apply
Medical Writer
BGBx —Remote
- $70,000 - $95,000 a year
- Full-time
- Remote
- Medicine
- Research
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
7d
Grant Writer
The Great Commission Church Inc. —Remote
- $250 - $600 a week
- Contract
- Remote
- Research
- Mid-level
- Contracts
Quick Apply
9d

I want to receive the latest job alert for program writer

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Clinical Medical Writer Consultant

Kaztronix -
San Diego, CA

Quick Apply

Job Details

Contract
6 days ago

Qualifications

Technical writing for researchers
Medical writing
Scientific protocols
Clinical data report preparation
Clinical research reports
Clinical trial support in drug product development

Full Job Description

Clinical Medical Writer

Position Summary

We are seeking an experienced Clinical Medical Writer to support the development of high-quality clinical and regulatory documents for an oncology-focused biotechnology company. This individual will play a key role in advancing multiple late-stage clinical programs, with primary responsibility for authoring and coordinating clinical study documentation for Phase 2 and Phase 3 trials.

The ideal candidate is a collaborative, detail-oriented writer who thrives in a fast-paced, resource-efficient environment and is comfortable managing multiple studies simultaneously. This role requires close partnership with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure timely delivery of accurate, scientifically rigorous documents.

Key Responsibilities

Author, edit, and manage clinical documents supporting Phase 2 and Phase 3 oncology clinical trials, including:
- Clinical Study Protocols and protocol amendments
- Investigator Brochures (updates)
- Clinical Study Reports (CSRs)
- Informed Consent Forms
- Clinical sections of briefing books and meeting packages
- Safety narratives and integrated clinical summaries, as needed
Contribute to regulatory documents including:
- IND submissions and amendments
- Responses to Health Authority information requests
- Annual reports
- Other regulatory documents as required
Manage writing activities for 2 3 concurrent clinical studies while balancing competing priorities and timelines.
Lead document planning, timelines, and cross-functional review cycles from document kickoff through finalization.
Collaborate with subject matter experts to translate complex scientific and clinical information into clear, accurate, and submission-ready documents.
Ensure documents comply with ICH, GCP, company SOPs, and applicable regulatory guidance.
Incorporate statistical outputs, clinical data, and safety information into clear scientific narratives.
Coordinate document reviews, reconcile comments, and maintain version control throughout document development.
Support preparation for regulatory interactions and major clinical milestones.
Contribute to process improvements, document templates, and writing standards appropriate for a growing biotechnology organization.

Qualifications

Advanced degree (PharmD, PhD, MD, MS, MPH, or equivalent scientific discipline) preferred; Bachelor's degree with significant relevant experience will be considered.
5 8+ years of medical writing experience in biotechnology, pharmaceutical industry, or CRO.
Demonstrated experience authoring clinical documents for Phase 2 and Phase 3 clinical trials.
Oncology clinical development experience required.
Experience preparing Clinical Study Reports and clinical study protocols required.
Working knowledge of regulatory submission documents (INDs, briefing documents, annual reports, responses to health authorities).
Strong understanding of ICH E3, ICH E6, GCP, and FDA/EMA regulatory expectations.
Ability to independently manage multiple writing projects with minimal supervision.
Excellent project management, organization, and communication skills.
Experience working within cross-functional clinical development teams.
Proficiency with Microsoft Office and document management systems; familiarity with electronic document review platforms preferred.

Preferred Qualifications

Experience supporting late-stage oncology development programs.
Experience with immuno-oncology, virology, or targeted therapies is a plus.
Experience supporting global clinical studies.
Familiarity with submission publishing processes and electronic Common Technical Document (eCTD) structure.

Success in This Role

The successful candidate will:

Produce high-quality clinical and regulatory documents that meet aggressive development timelines.
Effectively manage writing activities across 2 3 active clinical studies simultaneously.
Build strong partnerships with cross-functional stakeholders while driving documents to completion.
Adapt comfortably within a collaborative, fast-moving biotech environment where flexibility and initiative are highly valued.
Maintain scientific rigor, attention to detail, and regulatory compliance across all deliverables.

This position offers the opportunity to make a meaningful impact within a growing clinical-stage biotechnology company, contributing directly to the advancement of innovative oncology therapies through pivotal stages of clinical development.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Quick Apply

Refine Your Search

program writer jobs