Medical Writer 🔥
A pharmaceutical company in New Jersey is looking to add a new Medical Writer to their Global Regulatory Affairs Department in a Remote capacity. In this role, the Medical Writer (Remote) will be responsible for ensuring communications are complete, well organized & scientifically accurate, and that messaging is consistent throughout all technical documentation.
Responsibilities:
The Medical Writer (Remote) will:
- Proactively manage writing activities across assigned projects; ensure adherence to the medical writing strategy and alignment with business needs
- Contribute to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents
- Author deliverables with consideration for regulatory, corporate, departmental, and quality standards
- Adhere to medical writing practices/systems / tools to support clinical studies in order to meet company goals and objectives
- Assure that standardized practices are implemented and maintained across all therapeutic areas
- Engage with team members to ensure medical writing continues to deliver value to the business
- Ensure medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations
- Support innovation initiatives within the Medical Writing Group
- Perform other duties, as needed
Qualifications:
- 4+ years of related Clinical Research experience in a Biotechnology / Pharmaceutical setting
- Bachelor's Degree in Life Sciences and/or related field
- Demonstrated expertise in writing / developing clinical documents in support of Global Regulatory Submissions
- Ability to interpret and organize Scientific and Clinical Data
- Experience with ICH and electronic submission guidelines for regulatory reports
- Computer savvy
- Microsoft Office Suite proficient (Excel, Outlook PowerPoint, Word, etc.)
- Solid problem solving and time management skills
- Great interpersonal skills
- Excellent communicaiton skills (written and verbal)
- Strong attention to detail
- Highly organized
Desired Skills:
- Graduate Degree
- Medical Device background
- Experience with Electronic Document Management systems and other Content Authoring technologies
- Ability to work EST hours