Senior Strategic Medical Writer - Remote

BioSpace; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

AbbVie in the United States seeks a Senior Strategic Medical Writer to lead and write clinical and regulatory documents for drug and device development in support of company objectives.

In this role you will collaborate with cross-functional teams, ensure compliance with regulatory guidelines, and manage multiple projects with timely delivery. Strong writing and scientific communication skills are essential for success.

Qualifications

• 4+ years in bio-pharma writing for global pharma/biotech.
• Bachelor's degree or higher; scientific discipline preferred.
• Excellent written and oral communication in medical terminology.
• Experience writing and editing clinical/regulatory documents per ICH/GCP.
• Knowledge of CONSORT and PRISMA; EU/US device writing a plus.
• Understanding of drug development and regulatory requirements.

Responsibilities

• Prepares clinical and regulatory documents for drug and/or device development.
• Works with SMEs and senior writers for validation and review.
• Coordinates review, approval, and quality control across teams.
• Delivers documents within project timelines and quality standards.
• Develops knowledge of US and international regulatory guidelines.
• Contributes to process improvements and issue resolution.
• Collaborates with leadership and QA to support inspection readiness.

Skills

Clinical writing

Regulatory writing

Cross-functional collaboration

Project management

Scientific communication

Education

Bachelor's degree in life sciences

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com.
Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com.
Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com.
Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Senior Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.

Responsibilities

• Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices.
• Functions with a moderate degree of autonomy on draft materials but relies on review by subject matter experts and more senior writers for verification. Develop knowledge and understanding of submission strategies.
• 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.
• Produces and maintains clinical and regulatory documents focusing on quality and compliance and ensures delivery within project timelines. Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives.
• Develops knowledge of US and international regulations, requirements, and guidelines pertaining to the preparation of regulatory documentation. Understands and uses guidance associated with preparation of regulatory documentation.
• Participates in execution of tactical process improvements.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Works closely with leadership and R&D Quality Assurance to address inquiries and draft responses, supporting an inspection-ready approach.

Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• A minimum of 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/ therapies to a broad market across various therapeutic areas.
• Bachelor's Degree or higher required; scientific discipline preferred.
• 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.
• Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines. EU and US device writing experience is a plus.
• 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 communicates 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

• 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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html