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Medical Writer
Suna SolutionsPosted 1 weeks ago
About this role
Job Title: Medical Writer
Pay Rate: $70–$80 per hour
Duration: 16 weeks
Location: Remote
Schedule: Monday–Friday, 9:00 AM – 5:00 PM
Position Overview
We are seeking an experienced and detail-oriented Medical Writer to develop high-quality clinical and regulatory documentation in compliance with global industry standards and regulatory guidelines. This role requires close collaboration with cross-functional teams including Clinical, Regulatory, Biostatistics, Medical Affairs, and Quality Assurance to produce scientifically rigorous, clearly structured, and submission-ready documents.
This is an excellent opportunity for a skilled writer who thrives in a fast-paced environment and is passionate about transforming complex clinical data into clear, compliant regulatory content.
Key Responsibilities
Regulatory Document Authoring
Prepare, author, and manage a broad range of clinical and regulatory documents, including:
- Clinical Study Protocols (CSPs) and Protocol Amendments
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- Informed Consent Forms (ICFs)
- Common Technical Document (CTD) Modules (e.g., 2.5 Clinical Overview, 2.7 Clinical Summary)
- Regulatory briefing documents (FDA, EMA, and other global authorities)
- Periodic Safety Reports
- Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs)
- NDAs, BLAs, and MAAs
- Responses to regulatory authority queries
Clinical Development Support
- Contribute to clinical development plans and trial documentation
- Collaborate with clinical and statistical teams to ensure alignment with study objectives
- Interpret and communicate complex scientific and clinical data clearly and concisely
Regulatory Compliance & Standards
- Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable guidelines
- Stay current with evolving regulatory requirements and industry best practices
Collaboration & Project Management
- Work cross-functionally with medical, regulatory, clinical, statistical, and QA teams
- Review and edit documents from internal teams and external vendors
- Participate in regulatory strategy discussions and team meetings
- Drive timelines and manage multiple concurrent document development projects
Qualifications
Education
- Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field preferred
Experience
- 3–5+ years of medical writing experience within pharmaceutical, biotech, or CRO environments
- Strong experience developing regulatory documents for clinical trials and submissions
- Experience across drug development phases I–IV preferred
- Epilepsy or Neurology experience is a plus
Technical & Professional Skills
- Strong understanding of drug development, clinical research, regulatory requirements, and biostatistics
- Proficiency with ICH guidelines, GCP, FDA and EMA submission standards
- Familiarity with coding dictionaries (MedDRA, WHODrug)
- Excellent scientific writing, editing, and document structuring skills
- Ability to simplify complex scientific concepts for varied audiences
- High proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Experience with document management and publishing tools (EndNote, Adobe Acrobat, regulatory submission platforms)
- Experience with Veeva preferred
Core Competencies
- Strong analytical and critical thinking skills
- Exceptional written and verbal communication abilities
- High attention to detail and accuracy
- Ability to manage multiple priorities and meet deadlines
- Adaptability in a fast-paced, evolving environment
- Self-motivated with strong project management capabilities
- Collaborative, team-oriented mindset with excellent relationship-building skills
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMODATION
Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT
Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.