Principal Strategic Medical Writer (Remote)

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Job description

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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

The Principal Strategic Medical Writer is responsible for providing clinical and regulatory document support and advanced scientific writing expertise for multiple compounds or projects within a therapeutic area. Works with clinical and regulatory teams.

Responsibilities:

• Independently serves as a lead on a large variety of complex clinical and regulatory documents.
• Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects. Arranges and conducts review meetings with the team. Works closely with the team(s) on document authoring and content strategies.
• Communicates deliverables needed, writing process, and timelines to team members.
• Holds team members accountable to agreed-upon project dates.
• Contributes to project management strategies and develops ability to lead team members, driving submission objectives.
• Recommends, leads, and implements tactical process improvements.
• Maintains expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects.
• Works independently with Regulatory Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.

This role can be based remotely within the US.

Qualifications

• A minimum of 5+ 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit

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

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