Principal Strategic Medical Writer - Device

Abbvie Job Posting

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.

Job Description

Purpose

Responsible for leading and writing clinical and regulatory device and drug documents in support of company objectives for the Aesthetics therapeutic area.

Responsibilities

In Aesthetics we support drug and device documents globally. The writing team participates in writing documents from study start-up to those that support product approvals (e.g. briefing books, IND, protocol, CSR, NDA sections, and regulatory response as well as CER, IDE and PMA).

Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents.

Arranges and conducts review meetings with the team.

Works closely with the team(s) on document authoring and content strategies.

Communicates deliverables needed, writing process, and timelines to team members.

Holds team members accountable to agreed-upon project dates.

Contributes to project management strategies and develops ability to lead team members, driving submission objectives.

Recommends, leads, and/or participates in implementation/execution of tactical process improvements.

Develops expert knowledge of global regulations, requirements, and guidance associated with preparation of regulatory documentation.

Qualifications

A minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, medical aesthetics, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.

Bachelor's Degree or higher in a scientific discipline.

Experience authoring device-specific documents preferred (e.g. CERs, SSCPs, IDEs, PMAs).

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

Advanced understanding of drug and/or device development, clinical research, study designs, biostatistics, 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 abbvie.com/join-us/equal-employment-opportunity-employer.html

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