Principal Strategic Medical Writer (Remote)

AbbVie Inc; Boston (MA); Remote; USD 85,000 - 130,000; Full time

Job summary

An established industry player is seeking a Principal Strategic Medical Writer to lead the creation of clinical and regulatory documents. This role is pivotal in ensuring compliance with US and international regulations while driving project management strategies. The ideal candidate will possess outstanding communication skills and a strong background in the bio-pharmaceutical sector. Join a forward-thinking company that values innovation and offers a comprehensive benefits package, including paid time off and participation in incentive programs. This is an exciting opportunity to make a significant impact in the field of medical writing.

Benefits

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Short-term Incentive Programs

Long-term Incentive Programs

Qualifications

• 5+ years in bio-pharmaceutical industry with strong writing skills.
• Expertise in regulatory documentation and communication.

Responsibilities

• Independently write clinical and regulatory documents.
• Coordinate review and approval processes with cross-functional teams.
• Develop expert knowledge of regulations and guidelines.

Skills

Written Communication

Oral Communication

Data Analysis

Project Management

Regulatory Knowledge

Problem Solving

Education

Bachelor's Degree in Scientific Discipline

Job description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents that support the company's objectives.

Responsibilities

1. The Principal Strategic Medical Writer independently writes most clinical and regulatory documents within their remit. They coordinate the review, approval, and quality control processes involving other functions in the production of clinical and regulatory documents. They arrange and conduct review meetings with the team to ensure thorough examination of content. The writer works closely with teams on document authoring and content strategies to ensure alignment with project goals.
2. The writer communicates deliverables needed, the writing process, and timelines to team members, ensuring clarity and understanding of expectations. They hold team members accountable to agreed-upon project dates, contributing to the success of timely submissions.
3. The writer contributes to project management strategies and develops the ability to lead team members, driving toward submission objectives. They recommend, lead, and participate in the implementation and execution of tactical process improvements to enhance efficiency and effectiveness.
4. The writer develops expert knowledge of US and international regulations, requirements, and guidance associated with the preparation of regulatory documentation. They identify and propose solutions to resolve issues and questions that arise during the writing process, including resolution or escalation as appropriate.
5. The writer learns and applies therapeutic area and product knowledge to scientific projects and business improvement initiatives. They work independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.

Qualifications

• Required Qualifications:

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.

Bachelor's Degree or higher in a scientific discipline

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, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines.

Advanced 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 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.

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 of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and 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.
• This job is eligible to participate in our long-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 any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 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