Senior Medical Writer

Remote Senior Medical Writer

On-Board Services is hiring a Remote Senior Medical Writer. For immediate consideration, please send your resume to resumes@onboardusa.com. Subject Line: Position Title and State you are located.
About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full-time positions to our employees. We offer benefits as well as 401k.
Position Details:
Title: Senior Medical Writer
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Remote
Shift: 1st Shift – Eastern Standard Time
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance, PTO
Compensation: $83.52/HR
Position Summary: This role is accountable for Medical Writing and is part of the Regulatory Operations organization. The Senior Medical Writer will support the preparation of clinical regulatory documents across a variety of regulatory filings and work as a member of the Medical Writing team, reporting to the Head of Medical Writing. The successful candidate will be responsible for writing clinical and regulatory documents including, but not limited to, Investigator's Brochures, Protocols and Protocol Amendments, Clinical Study Reports (CSRs), Agency Background Packages, Responses to Agency Inquiries, and clinical modules of INDs, NDAs, BLAs, MAAs, and other regulatory submissions.
Responsibilities:
Manage assigned writing projects and ensure documents adhere to relevant regulatory guidelines, SOPs/WIs, templates, and style guides.
Manage multiple documents simultaneously and ensure timely, high-quality completion of Medical Writing deliverables.
Ensure documents contain appropriate scientific content and context, clear and consistent messaging, and are accurate, complete, and compliant with applicable regulatory and editorial standards.
Initiate and lead strategy and issue-resolution meetings as needed.
Drive collaboration and clear handoffs among key stakeholder groups, including Clinical, Safety, Regulatory, and Non-Clinical teams.
Partner with vendors and external resources to support Medical Writing activities.
Contribute to the development, alignment, and consistent implementation of Medical Writing processes.
Ensure compliance with internal processes and maintain inspection readiness.
Assist in the preparation and revision of document templates, SOPs, guidance documents, and other process documentation.
Support content authoring, quality assurance, and formatting standards within the global content authoring platform.
Participate in CRO alliance and outsourcing activities as needed.
Qualifications:
Bachelor of Science degree in Life Sciences, Nursing, Pharmacy, or a related discipline required
Master's degree, PhD, or PharmD preferred
Required Experience and Skills:
Minimum of 7 years of medical writing experience within the pharmaceutical industry
Experience serving as lead writer for key documents included in major US, EU, and/or international regulatory submissions
Strong understanding of clinical development, including phases, processes, and techniques used from protocol design through regulatory submission and post-marketing support
Knowledge of FDA and international regulations, ICH guidelines, and regulatory processes related to document preparation and submission, including CTDs
Proven ability to think critically, strategically, and independently while solving complex problems
High level of motivation, initiative, and alignment with company leadership values
Strong time management and project management skills
Excellent written and verbal communication skills with the ability to write clearly and concisely
Excellent interpersonal skills, including the ability to navigate challenging situations effectively
Ability to collaborate across multiple functional areas
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner." On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics. JD# 25-00997 INDOJ