Medical Writer

Job Title: Medical Writer

Pay Rate: $60 to $64.19/Hr

Duration: 18 Months

Location: Remote

Shift - 8 AM to 5 PM Pacific time

Our Client is a Global medical device Manufacturer.

We are looking for a Medical Writer to develop accurate and effective Clinical, Scientific, and Regulatory documents and presentations for external scientific conferences and meetings

• Research, create, and edit moderately complex scientific publications and presentations of clinical research based on input from the Clinical Team, Key Opinion Leaders (KOLs), and physician investigators.
• Execute podium and publication plan in collaboration with internal and external stakeholders (e.g., physician investigators, KOLs).
• Maintain presence at national and international conferences while ensuring compliance with all regulatory requirements
• Develop complex scientific content (e.g. medical writing, editing, finalizing, manuscripts, abstracts, podium presentations, posters, publication review, scientific content review) and submit content to scientific congresses and medical journals, to support transcatheter heart valve scientific podium publication plan
• Lead the content evaluation and ensure alignment with relevant strategy by reviewing complex deliverables in collaboration with cross-functional teams (e.g. regulatory, research and development, biostatistics, clinical safety, marketing, and investigators) and provide recommendations and solutions for content improvement
• Conduct literature reviews to address study-specific questions; provide synopsis of findings
• Collaborate with team members to develop clinical data into context for the clinical community
• Write moderately complex clinical documents for submissions, including but not limited to briefing documents, previous human experience summaries, investigator brochures, 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 publications for all clinical studies in collaboration with KOLs
• Conduct literature searches, manage 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

Must-Have skills :

• Ability to understand medical data and display it in a manner consistent with evidence dissemination strategy
• Excellent problem-solving, organizational, analytical, and critical thinking skills
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel
• Excellent written and verbal communication skills with internal and external customer customers and relationship management skills

Additional Skills:

• 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 to the development of scientific publications and medical writing styles and techniques
• Moderate knowledge of conducting focused searches on medical literature databases (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 the environment and prevention of pollution under their span of influence/control

Education and Experience:

• Bachelor's Degree or equivalent in a related field
• 8-10 years of experience required

Preferred Skills :

• Cardiology experience
• Med device experience
• Experience with working with KOL/MD
• Knowledge of clinical trial execution