Senior Manager- AMCP Dossier Writer, Chicago

Job Description

The AMCP Dossier Writer is responsible for providing scientific/medical product dossier support and advanced scientific/medical writing expertise to the clinical teams, ensuring successful preparation of high-quality dossiers per the Academy of Managed Care Pharmacy (AMCP) Format, and effective implementation of the writing process. Provides scientific/medical writing expertise for multiple compounds within a therapeutic area or across therapeutic areas. Interfaces with stakeholders within Value and Access (leadership, medical outcomes science liaison [MOSL], medical review), and external groups (medical, global medical information (GMI), Health Economics and Outcomes Research [HEOR]) to ensure accurate and timely completion of dossier content and review and approvals of AMCP Dossiers for dissemination aligning with product label approval or other timelines as needed. Serves as the scientific/medical writing content expert for Value and Access within U.S. Medical Affairs.

Responsibilities:

Serves as scientific/medical writing lead on more complex and demanding therapeutic area product dossiers and/or unapproved product or unapproved use dossiers. Works closely and effectively with the dossier core teams (DCT) consisting (at a minimum) of USMA Medical Payor Strategy Lead (or designee),  Health Economics and Outcomes Research (HEOR), Global Medical Information (GMI), and Value and Access Medical Review. Develops strategic activities related to the preparation of different dossiers by compilation of available data and scientific information on products into a single comprehensive and concise dossier.

Serves as a subject matter expert within Value and Access for assigned or different therapeutic/product areas. Provides direction and guidance to other medical writers regarding assigned projects, including review/consult of work product. Resolve any queries on the content and/or processes related to dossiers.

Provides input and feedback to management regarding internal medical writers’ work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides resolution.

Shows expertise in explaining scientific/medical content of the work product in manner consistent with the target audience(s) in the United States and Puerto Rico Health Care Organizations (HCO) or Health Care Institutions (HCI) for use in connection with formulary decision making. Provides expertise in developing the content that is scientifically balanced, non-commercial and without any promotional language.

Responsible for effective communication among team members. Setting up the DCT, in consultation with USMA Medical Payor Strategy Lead (or designee), and the expectations of its members including timelines, timely completion of reviews, and discharge of the assigned tasks.

Responsible for coordination of the review of the work products through various functions at different stages of draft and reconcile the comments and/or edits maintaining the quality and control measures including spelling, editing, grammatical corrections, and formatting. Provides leadership in the negotiations with functional areas on project outcomes and deliverables to meet conflicting demands. Must identify and resolve conflicts including dossier content issues, remove barriers, generate innovative ways to ensure teams achieve project goals to meet the scheduled timelines.

Responsible for final approval processes in the company assigned platform and maintain the documentation of such approvals aligned with the compliance. Must project manage the dossier projects effectively.

Serves as a point person for the departmental leadership in providing the status reports periodically on the dossier development, dissemination, and usage by the end users. Contribute to overarching departmental objectives and goals.

Contribute to the development of other medical writers including coaching and mentoring. Recommends and leads the efforts in developing and implementing the tactical process improvements that affects own work products and others in the team.

Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing of AMCP dossiers.