On-Board Services is hiring a Remote Senior Medical WriterFor immediate consideration please send your resume to Subject Line: Position Title and State you are located 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 SummaryThis 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.
QualificationsEducation - 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
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