AbbVie
Senior Strategic Medical Writer - Remote
Chicago, IL, United States · Senior
Sponsorship not specifiedDetected 22 hours ago
GCPProject ManagementClinical TrialsClinical ResearchPharmacologyResearchLeadershipCommunicationProblem SolvingTime ManagementBiostatistics
About the role
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Responsibilities
- Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices.
- 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.
- Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills.
- Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements.
- Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams.
Requirements
- Functions with a moderate degree of autonomy on draft materials, but relies on review by subject matter experts and more senior writers for verification.
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
- Bachelor's Degree or higher required; scientific discipline preferred.
Nice to have
- Bachelor's Degree or higher required
- scientific discipline preferred.
- Familiarity with industry standards like CONSORT and PRISMA guidelines.
- EU and US device writing experience is a plus.
Skills
- Strong organizational, time management, and problem-solving skills.
Benefits
- 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.
- The S enior Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.
- 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.
- Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
- Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
- Effectively communicates complex scientific and medical information to various stakeholders.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Company info
- 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.
Equal opportunity
- Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://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
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.