Regulatory Medical Writer (Remote)

• Research, create, and edit moderately complex scientific documents and presentations of clinical research based on input from the Clinical Team, Key Opinion Leaders (KOLs), and physician investigators
• Write moderately complex clinical documents for regional regulatory submissions, including but not limited to: briefing documents, previous human experience summaries, investigator brochures, study protocols, informed consents, and interim and final clinical study reports for the assigned projects
• Provide guidance to the Clinical team to develop the publication strategy and plans; create and may edit publication for all clinical studies in collaboration with KOLs
• Conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
• Review draft publications for accuracy and continuity with previously published work and submitted regulatory documents
• Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues
• Other incidental duties assigned by Leadership

• Ability to provide leadership and guidance; skilled in coaching and training techniques
• Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)
• Good editing and proofreading skills
• Good written and verbal communication skills including negotiating and relationship management skills
• Good problem-solving and critical thinking skills
• Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
• Moderate knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
• Moderate knowledge of statistics
• Strict attention to detail
• Ability to interact professionally with all organizational levels and functions where appropriate
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

• Bachelor's Degree or equivalent in in related field
• 5-7 years of experience required

Hydrogen Group