Health Technology Assessment (Hta) Writing Senior Manager (Medical Writing Senior Manager)

Amgen Inc. Thousand Oaks , CA 91360

Posted 6 days ago

Career CategoryHealth EconomicsJob Description

Amgen is seeking a Health Technology Assessment (HTA) Writing Senior Manager. The focus of this position will be the writing of national HTA, Access and Reimbursement dossiers and related deliverables, with the aim of helping to secure optimal access and reimbursement for patients. The role is based in Amgen's Health Technology Assessment Center of Excellence (HTA CoE), reporting to the Head of HTA Writing and working closely with HTA Leads, HTA Project Managers and country affiliates.

This position can be based at Amgen's headquarters in Thousand Oaks, California or remote-based in the United States.

Responsibilities include:

Prepare (and oversee the preparation of) National HTA, access and reimbursement dossiers (e.g., AMCP, CADTH, NICE), Global Value Dossiers (GVDs), responses to payer questions, and HTA/Payer engagement briefing documents.

Write (or oversee the writing of) HTA sections according to specific payer requirements and HTA templates, e.g.: Disease Background, Burden of Illness, Current Treatment and Unmet Need, Description of Product and Place in Treatment Pathway, Clinical Evidence of Efficacy/Safety and Economic Analyses.

Compile evidence, extracts and summarize information from a range of source documents: GVDs, Regulatory Reports, Literature Reviews, Evidence Synthesis Reports, Clinical Study Reports, Publications, Technical Economic Reports

Work with cross functional teams to develop a compelling, evidence-based narrative within submissions, to clearly demonstrate the value of new Amgen medicines to payers.

Manage document production and version control throughout the dossier development process to finalization, ensuring quality of submission documents at all stages of development, seamless integration of clinical and economic components and finalization of full HTA submission package (with appendices and references).

If necessary, manage workload for supporting external writers

Share best practice and improvements in HTA Writing Processes

Basic Qualifications:

Doctorate degree and 2 years of health economics experience, or health economics and medical writing experience

OR

Master's degree and 6 years of health economics experience, or health economics and medical writing experience

OR

Bachelor's degree and 8 years of health economics experience, or health economics and medical writing experience

OR

Associate's degree and 10 years of health economics experience, or health economics and medical writing experience

OR

High school diploma / GED and 12 years of health economics experience, or health economics and medical writing experience

Preferred Qualifications:

Masters, PharmD or PhD in Health Economics or related scientific field e.g. biology, chemistry or other scientific discipline).
5+ years of preparing a wide range of national and global payer/HTA documents.

Ability to present complex clinical and health economic data aligned with specific payer requirements.

Advanced written/oral communication skills and attention to detail

Advanced knowledge of HTA and scientific/technical writing and editing.

Experienced in creating standard operating procedures and best practices guidance for the dossier development process.

Extensive experience of managing cross-functional matrix within pharma, liaising with range of functions.

Ability to effectively operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment

Knowledge of management skills and supervising the work of others

Strong leadership in a team environment

Strong negotiator

Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Health Technology Assessment (Hta) Writing Senior Manager (Medical Writing Senior Manager)

Amgen Inc.