Job Description

Purpose

The medical writer is responsible for providing clinical regulatory document support to clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the clinical writing process. The medical writer: provides medical writing expertise for multiple compounds and/or projects within a therapeutic area or potentially across a therapeutic areas; interfaces with external groups (e.g., Pharmacokinetics, Toxicology, eSubmissions, Regulatory, Statistics, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions and participates in process improvement activities.

Responsibilities

• Assists with or implements activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated regulatory documents. Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams and Medical Writing mentor/management. Able to write less complex document types, such as protocols, with little supervision. Requires close supervision/mentoring on more complex document types
• Effectively communicates clinical regulatory 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 ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
• 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 RQA document audit process and works with team and manager to draft responses as necessary.
• Produces and maintains clinical documents focusing on quality and compliance and ensures delivery within project timelines.
• Familiarity with US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation

Qualifications

Qualifications

• A minimum of 2+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
• 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.
• Extensive experience writing, editing clinical documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines.
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors.
• Excellent writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders.
• Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills.

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. ​​

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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.

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