What AbbVie Has to Offer: Our work can鈥攁nd does鈥攈ave a tangible, lasting impact on millions of people. But it鈥檚 not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.
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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 鈥� immunology, oncology, neuroscience, and eye care 鈥� and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at聽. Follow @abbvie on聽,听,听,听,听听补苍诲听.
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鈥檚 mission to deliver innovative medicines and solutions that address multifaceted health issues and enhance people's lives.
As a Principal Strategic Medical Writer聽at AbbVie, you will be responsible for leading and writing clinical and regulatory documents in support of company objectives.聽
Your role responsibilities:
- Independently write聽most clinical and regulatory documents within remit. Coordinate聽the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. Arrange聽and conducts review meetings with the team. Work聽closely with the team(s) on document authoring and content strategies.
- Communicate聽deliverables needed, writing process, and timelines to team members.
- Hold聽team members accountable to agreed-upon project dates.聽
- Contribute聽to project management strategies and develops ability to lead team members, driving submission objectives.
- Recommend, leads, and/or participate聽in implementation/execution of tactical process improvements.聽聽
- Develop聽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聽and apply聽therapeutic area and product knowledge to scientific projects and business improvement projects.
- Work聽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聽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聽 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聽local law:聽鈥�
The compensation range described below is the range of possible base pay compensation that the Company聽believes in聽good faith it will pay for this role at the time聽of this posting based on the job grade for this position.聽Individual聽compensation paid within this range will depend on many factors including geographic location, and聽we聽may ultimately聽pay more or less than the posted range. This range may be modified in the聽future.鈥�
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),听medical/dental/vision聽insurance and 401(k) to eligible聽employees.鈥�
This job is eligible to participate in our short-term incentive聽programs.聽鈥�
This job is eligible to participate in our long-term incentive聽programs鈥�
Note: No amount of pay聽is considered to be聽wages or compensation until such amount is earned, vested, and聽determinable.聽The amount and availability of any bonus,听commission, incentive, benefits, or any other form of聽compensation and benefits聽that are allocable to a particular employee remains in the Company's sole and聽absolute聽discretion unless and until paid and聽may be modified at the Company鈥檚 sole and absolute discretion, consistent with聽applicable law.聽鈥�
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.鈥� Equal Opportunity Employer/Veterans/Disabled.聽
US & Puerto Rico only - to learn more, visit聽
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