Senior Strategic Medical Writer Remote

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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. Develops 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 :

Bachelors Degree or higher required; scientific discipline preferred.
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.
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 :

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 ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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 visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes

Employment Type :

Full-time

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.Funct...

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. Develops 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 :

Bachelors Degree or higher required; scientific discipline preferred.
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.
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 :

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 ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.

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 visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes

Employment Type :

Full-time

Key Skills

Clinical Research
Adobe Acrobat
FDA Regulations
Technical Writing
Biotechnology
Clinical Development
Clinical Trials
Microsoft Powerpoint
Research Experience
Document Management Systems
Word Processing
Writing Skills

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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