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Manager, Strategic HTA Writer
Location
Germany
Posted
92 days ago
Salary
0
Seniority
Senior
Job Description
Manager, Strategic HTA Writer
AbbVie
• Able to write less complex document types (unmet need, disease burden sections), with little supervision. • Requires close supervision/mentoring on more complex document type and relies on review of subject matter experts and more senior writers for verification. • Effectively communicates JCA document deliverables needed, writing process, and timelines to team members. • Holds team members accountable to agreed-upon project dates. • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including elevation as appropriate. • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per EU HTA regulations and guidance materials. • Arranges and conducts review meetings with the team. • Acts as interface to resolve issues and questions arising during the writing process. • Works with manager throughout the document audit process and works with JCA Core team and manager to draft responses as necessary. • Produces and maintains focusing on quality and compliance and ensures delivery within project timelines. • Familiarity with HTA dossier regulations, requirements and guidance associated with EU HTA regulations.
Job Requirements
- A minimum of 3+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, HTA agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
- Extensive experience in writing HTA dossiers, eg AMNOG, HAS, NICE, CDA dossier preferred.
- Bachelor's Degree or higher in a scientific discipline.
- Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
- Proficient in assimilating and analyzing complex data.
- Advanced understanding of HTA dossiers and HTA requirements, clinical research, study designs, biostatistics.
- Good understanding of regulatory requirements, and medical terminology cross functional teams and multiple contributors.
- Excellent English writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders.
- Ability to collaborate with cross-functional teams.
- Strong organizational, time management, and problem-solving skills.
Benefits
- Equal Opportunity Employer/Veterans/Disabled
- Committed to operating with integrity
- Driving innovation
- Transforming lives
- Serving our community
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About us: Welcome to the American Straight A Academy (ASAA), a distinguished K-12 online school dedicated to extending American education globally. Our mission is to provide a transformative "American education at your fingertips—everywhere!" experience for students worldwide. Committed to empowering as many students as possible, we enhance portfolios for college acceptance by offering a U.S. high school studying experience. Explore this unique opportunity for your children, fostering a positive impact that resonates throughout their lives. Join ASAA in shaping brighter educational futures. Open classes: - Subject 1: AP English Literature and Composition Preference working time: (Pacific Time) 10:00 pm ~ 00:30 am Option 1: Monday, Wednesday & Friday Option 2: Sunday, Tuesday & Thursday - Subject 2: AP Seminar Preference working time: (Pacific Time) Sunday, Tuesday & Thursday Option 1: - 6:00 pm ~ 9:00 pm Option 2: 10:00 pm ~ 00:30 am Qualifications and Requirements: - Bachelor's degree in the relevant subject area; Master’s or Ph.D./EdD is preferred. - A minimum of 1 year of teaching experience in the relevant subject area, with high school teaching experience considered advantageous. - Able to offer at least 3 available time slots during weekdays. - Cooperative demeanor with staff, a passion for teaching, and a flexible schedule for evenings and weekends. Your Responsibilities: - Deliver group (2-6 students) online instruction. - Utilize pre-existing teaching materials to ensure thorough comprehension of the subject matter. - Assess and grade students' in-class performance, providing constructive feedback to facilitate academic progress. - Ensure timely completion of the curriculum within designated timelines. Job Type: Part-time Contact: Emily.liu@asaaeducation.com This is a remote position.
