Medical Writer Clinical Development
Sunrise Systems Inc
- Marlborough, MA
- 3 days ago
- Remote
- $100–$112 Per Hour
Highlights
Collaborate with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, to gather, interpret, and integrate scientific and clinical information into clear, accurate, and submission-ready documents. This role works closely with cross-functional stakeholders to ensure documents are scientifically accurate, strategically aligned, and delivered according to established timelines and medical writing plans.
Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $100–$112 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: Medical Writer – Clinical Development
Location: remote - Marlborough, MA
Duration: 07 Months of W2 contract
Job Description:
Position Summary
The Medical Writer is responsible for authoring, reviewing, and coordinating the development of high-quality clinical and regulatory documents that support global clinical development programs. This role works closely with cross-functional stakeholders to ensure documents are scientifically accurate, strategically aligned, and delivered according to established timelines and medical writing plans.
Key Responsibilities
Location: remote - Marlborough, MA
Duration: 07 Months of W2 contract
Job Description:
Position Summary
The Medical Writer is responsible for authoring, reviewing, and coordinating the development of high-quality clinical and regulatory documents that support global clinical development programs. This role works closely with cross-functional stakeholders to ensure documents are scientifically accurate, strategically aligned, and delivered according to established timelines and medical writing plans.
Key Responsibilities
- Author, edit, and review clinical and regulatory documents, including:
- Clinical study protocols and protocol amendments
- Investigator Brochures (IBs)
- Clinical Study Reports (CSRs)
- Briefing Book support
- IND and NDA summary documents and other regulatory submission materials
- Develop documents that are consistent with regulatory requirements, internal standards, and medical writing plans, while supporting the overall clinical development lifecycle and program objectives for one or more clinical development programs.
- Collaborate with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, to gather, interpret, and integrate scientific and clinical information into clear, accurate, and submission-ready documents.
- Negotiate document deliverable milestones and timelines with cross-functional teams to ensure alignment across functions and adherence to medical writing plans and program objectives.
- Facilitate document review cycles, resolve reviewer comments, and drive consensus among stakeholders while maintaining quality and schedule commitments.
- Ensure documentation complies with applicable regulatory guidance, Good Clinical Practice (GCP), company standards, and industry best practices.
- Contribute to the development and continuous improvement of medical writing processes, templates, style guides, and operational procedures.
- Support regulatory submissions, health authority interactions, and inspection readiness activities as needed.
Core Competencies
- Scientific and regulatory writing expertise
- Project and timeline management
- Cross-functional collaboration and influence
- Strategic thinking and problem solving
- Attention to quality and regulatory compliance
- Effective communication and stakeholder management
Skills:
Qualifications
Qualifications
- Advanced degree Bachelor's degree or more.
- Experience authoring clinical and regulatory documents within the pharmaceutical, biotechnology, or clinical research industry.
- Strong knowledge of clinical development, regulatory requirements, and applicable guidance documents (e.g., ICH guidelines).
- Excellent scientific writing, editing, and communication skills.
- Demonstrated ability to manage multiple projects and negotiate timelines in a cross-functional environment.
- Strong organizational skills, attention to detail, and ability to work independently and collaboratively.
Education:
- Advanced degree Bachelor's degree or more
Compensation:
The hourly rate for this position is between $100-112.00 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.