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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 â€� immunology, oncology, neuroscience, and eye care â€� and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on ,Ěý,Ěý,Ěý,ĚýĚý˛ą˛Ô»ĺĚý.
AbbVie's Strategic Medical Writing team within the Specialty therapeutic area is dedicated to creating high-quality, evidence-based documents that support the development and communication of innovative therapies. We are recognized as leaders in medical writing, driving success through strategic insights and scientific excellence. We foster a collaborative environment which enables us to transform complex scientific data into clear, impactful narratives fulfilling AbbVie’s mission to deliver innovative medicines and solutions that address multifaceted health issues and enhance people's lives.
As a Principal Strategic Medical Writer at AbbVie, you will be responsible for leading and writing clinical and regulatory documents in support of company objectives.Â
Your role responsibilities:
- Independently write most clinical and regulatory documents within remit. Coordinate the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. Arrange and conducts review meetings with the team. Work closely with the team(s) on document authoring and content strategies.
- Communicate deliverables needed, writing process, and timelines to team members.
- Hold team members accountable to agreed-upon project dates.Â
- Contribute to project management strategies and develops ability to lead team members, driving submission objectives.
- Recommend, leads, and/or participate in implementation/execution of tactical process improvements. Â
- Develop expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
- Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Learn and apply therapeutic area and product knowledge to scientific projects and business improvement projects.
- Work independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.
As a qualified candidate, you hold a Bachelor's Degree or higher in a scientific discipline and have 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.
You also demonstrate the following knowledge and skills:
- Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
- Excellent writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders.
- 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.
- Proficient in assimilating and analyzing complex data
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
- Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills.
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),Ěýmedical/dental/vision insurance and 401(k) to eligible employees.â€�
This job is eligible to participate in our short-term incentive programs. �
This job is eligible to participate in our long-term incentive programs�
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,Ěýcommission, 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. â€�
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.â€� Equal Opportunity Employer/Veterans/Disabled.Â
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