Medical Writer Job at System One, New Haven, CT

c3NJUmZRaUVZYTlxQXMxL29VZVpmeENvQXc9PQ==
  • System One
  • New Haven, CT

Job Description

Job Title: Medical Writer (part time)
Location: Northeast (EST) candidates preferred

Hours: 30 hours/month (7-8 hours/week)
Type: Contract (C2C or W2)

Job Purpose
The Translational Research Medical Writer plays a key role in the development and finalization of clinical research documents, supporting the creation of Informed Consent Forms (ICFs), clinical protocols, and imaging study reports (ISRs) for early phase molecular imaging studies. Additionally, if qualified, the writer will support FDA Investigational New Drug (IND) document development (Module 2). The role ensures document quality, consistency, and regulatory compliance while collaborating closely with internal and external cross-functional clinical research teams (Chemistry, Clinical, Quality Assurance, Project Management, Regulatory, Image Analysts, Scientists, Investigators, Operations, Medical Monitors, etc.)

Requirements
  • Bachelor’s degree in Life Sciences, Health Sciences, or related field required. Master’s degree preferred.
  • Minimum 3 years of experience writing scientific, medical, or technical content, preferably in a clinical research setting.
  • Experience with clinical protocol development, ICF development, and ISR development preferred.
  • Experience in managing multiple content and studies at different stages.
  • Knowledge of medical terminologies and jargon.
  • Demonstrated understanding of clinical research, drug development processes, and regulatory requirements (e.g., FDA, EMA).
  • Strong grasp of Standard Operating Procedures (SOPs) and regulatory writing best practices.
  • Experience in molecular imaging (PET, SPECT, MRI) is a plus.
  • English: Fluent
  • Broad and in-depth expertise in medical and scientific writing, particularly in clinical research documentation.
  • Understanding of clinical research processes, drug development, and regulatory guidelines.
  • Excellent written and verbal communication skills with the ability to translate complex scientific concepts into clear and concise documents.
  • Strong organizational skills, with keen attention to detail and the ability to manage multiple tasks efficiently.
  • Experience in managing multiple content and studies at different stages.
  • Proficiency in using document management systems and Microsoft Office Suite (Word, Excel, PowerPoint).
  • Ability to work independently and collaboratively in a cross-functional team environment.
  • Knowledge of molecular imaging, radiopharmaceuticals, and translational research is preferred.
Key Responsibilities
  • Development of study-specific documents
  • Draft, edit, and finalize high-quality ICFs, clinical protocols, and ISRs
  • Assist in the preparation of FDA IND Module 2 content, ensuring alignment with regulatory standards.
  • Translate complex scientific data into clear, user-friendly information.
  • Collaboration with cross-functional teams
  • Work closely with internal teams (Chemistry, Project Management, Regulatory, etc.) and external stakeholders to ensure consistency and accuracy in document development.
  • Collaborate with medical experts and researchers to gather information.
  • Standardization & Process Improvement
  • Develop and maintain document templates and reusable content to improve efficiency and consistency across projects.
  • Document Management
  • Oversee and coordinate document development for assigned projects, ensuring timely completion and compliance with client and regulatory requirements.
  • Ensure all documents meet applicable regulatory guidelines and company quality standards and are appropriately stored and organized. 
  • Ensure accuracy and consistency in all written materials.
  • Review and edit content for clarity, grammar, and technical accuracy.
  • Process Documentation
  • Contribute to the creation, documentation, and implementation of medical writing processes to enhance efficiency and best practices.

Benefits:
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 

Ref: #568-Clinical

Job Tags

Contract work, Part time,

Similar Jobs

TransPerfect

Email Marketing Specialist Job at TransPerfect

The Email Marketing Specialsit is responsible for nurturing unqualified leads to qualification...  ...Get notified about new Email Marketing Specialist jobs in Chicago, IL .Chicago, IL $65,0...  ...Dynamic Digital Marketing Executive - Fully Remote Opportunity Chicago, IL $50,000.00-$70,... 

All HealthCare Staffing, LLC

Interventional Cardiologist - Beautiful Houston Suburb - Excellent Compensation Job at All HealthCare Staffing, LLC

We are looking for a BC/BE Interventional Cardiologist with experience to join an established health system in the Houston, Texas area:Join a busy practice Growing team and an excellent support staffState of the art technologyLive and work in a place where energy abounds... 

UNLEADED

Associate Creative Director - Copy Job at UNLEADED

 ...The Associate Creative Director Copy is a pivotal player-coach role at Unleaded, balancing leadership with hands-on creative contribution. Youll guide, inspire, and mentor a team of writers and cross-functional creatives while developing standout copy that delivers... 

Bowen Scarff Ford

Auto Parts Delivery Driver Job at Bowen Scarff Ford

Benefits* 401(k) + 3% Match* 100% Employee Medical, Dental, Vision insurance* Mon - Fri* 9 Paid holidays* Part and Vehicle Discounts* Vacation & PTOFull job descriptionBowen Scarff Ford in Kent is looking to add aPARTS DRIVERThe Parts Driver...

NOVA

Network Engineer Job at NOVA

 ...installations or escalations. - Strong communication and documentation skills. Preferred Qualifications - Certifications: CompTIA Network+, CCNA, or equivalent. - Experience with cloud-managed networks (e.g., Meraki, UniFi Cloud Controller). - Familiarity with...