Principal Strategic Medical Writer (Remote)

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

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

Responsibilities

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. 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. 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. 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. 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 orlocal law:

• 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 the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at 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 #J-18808-Ljbffr Remote About the Company: Initial Therapeutics, Inc. Apply Job!