BioSpace
Principal Strategic Medical Writer, Aesthetics
BioSpace, South Chicago Heights, Illinois, United States
Principal Strategic Medical Writer, Aesthetics
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Principal Strategic Medical Writer, Aesthetics
role at
BioSpace
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.
Job Description Responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives in the aesthetic therapeutic area.
Responsibilities
Coordinate the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents.
Arrange and conduct 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.
Contribute to project management strategies and develop ability to lead team members, driving submission objectives.
Recommend, lead and/or participate in implementation/execution of tactical process improvements.
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.
Qualifications
A minimum of 5+ years of bio‑pharmaceutical industry experience in a global pharma, biotech, life science, medical aesthetics, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
Bachelor's Degree or higher in a scientific discipline.
Experience authoring device‑specific documents preferred (e.g. CERs, SSCPs, IDEs, PMAs).
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, ISO, and other regulatory requirements.
Advanced understanding of drug and/or device development, clinical research, study designs, biostatistics, 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.
Benefits and Compensation 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 and long‑term incentive programs.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Marketing, Public Relations, and Writing/Editing
US & Puerto Rico only – US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable‑accommodations.html
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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Principal Strategic Medical Writer, Aesthetics
role at
BioSpace
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.
Job Description Responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives in the aesthetic therapeutic area.
Responsibilities
Coordinate the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents.
Arrange and conduct 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.
Contribute to project management strategies and develop ability to lead team members, driving submission objectives.
Recommend, lead and/or participate in implementation/execution of tactical process improvements.
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.
Qualifications
A minimum of 5+ years of bio‑pharmaceutical industry experience in a global pharma, biotech, life science, medical aesthetics, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
Bachelor's Degree or higher in a scientific discipline.
Experience authoring device‑specific documents preferred (e.g. CERs, SSCPs, IDEs, PMAs).
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, ISO, and other regulatory requirements.
Advanced understanding of drug and/or device development, clinical research, study designs, biostatistics, 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.
Benefits and Compensation 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 and long‑term incentive programs.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Marketing, Public Relations, and Writing/Editing
US & Puerto Rico only – US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable‑accommodations.html
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.
#J-18808-Ljbffr