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