Principal Strategic Medical Writer Device
Principal Strategic Medical Writer Device
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Salary Not Disclosed
1 Vacancy
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.
Bachelors 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 Companys sole and 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:
Yes
Employment Type :
Full-time
Employment Type
Remote
