Purpose:

Write and edit high-quality, medically relevant AMCP dossiers for assigned therapeutics areas or assets to fulfill medical, scientific, and health economic objectives. Ensure successful preparation of high quality submission-ready documents and effective implementation of writing process and serve as AMCP dossier writing expert for the department.

Responsibilities:

• Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers
• Collaborate with therapeutic area leads to incorporate TA strategies, scientific platforms, value messages into AMCP dossier
• Collaborate with Global Medical Information to develop and/or edit responses to address specific unsolicited payer and health care provider requests for health outcome information
• Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and policies and procedures, and are used to appropriately respond to inquiries from payers and health care providers
• Provide medical writing support for multiple assets within a therapeutic areas.
• Understand, assimilate, and interpret sources of information with appropriate guidance/direction from team members.
• Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify the results are consistent with study data.
• Perform literature searches for drafting AMCP dossiers
• Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines
• Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate
• Maintains awareness of current industry practices that pertain to Corporate Policies and Procedures. Must continually train/be compliant with all current industry and company requirements
• Complies with the reporting of adverse effects and product complaints to Pharmacovigilance and Surveillance

Qualifications:

• Pharm. D., Ph.D., or equivalent
• Experience in the development of AMCP dossiers and documents related to outcomes research; understanding of model documents (templates) and how to use them correctly
• 3-5 years relevant industry work experience; recognized expert in medical communications and medical writing; extensive, proven experience and skill in writing high-quality, evidence-based scientific documents
• Proficient in managed care or access; previous experience in formulary or evidence-based evidence writing, review and assessments, and knowledge in evidence-based healthcare decision-making processes
• Ability to assimilate and interpret scientific content, and translate information for appropriate audience
• HEOR technical training is a plus
• Working knowledge of statistical concepts and techniques
• Highly proficient in the use of MS Word and Powerpoint

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)