Job Details

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

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.

• Qualifications

Qualifications:

• Bachelor of Science (BS) required, with significant relevant writing experience in AMCP Product Dossiers. Masters or PhD in biological sciences discipline preferred with relevant medical writing experience.

• For BS candidates, 6-8 years of relevant industry experience in medical writing in the healthcare/pharmaceutical industry or academia required or in a related area such as clinical research, or product development/research and development.

• For candidates with MS or PhD in science disciplines, 2 years of relevant industry experience in medical writing required.

• Must have high-level understanding of clinical study design and clinical/preclinical data interpretation preferred as evidenced by substantial publications in peer-reviewed journals.

• Excellent written and oral communication skills and attention to details. Must be able to influence the team members in issue resolution.

• Expert in word processing, PowerPoint, Excel spreadsheets, Microsoft Project, GraphPad Prism and other software programs in Windows.

• Must have exhibited experience working in collaborative environment across the functional areas including project management.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.?

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?

• This job is eligible to participate in our short-term incentive programs. ?

• This job is eligible to participate in our long-term incentive programs?

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ?

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Salary: $106,500 - $202,500