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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Principal Writer (PW) is responsible for providing RA strategic document expertise and support to one or more TAs as designated by RSW leadership. The PW provides support for the preparation and submission of critical RA documents and responses to health authority information requests using available reference materials such as documentation of previous interactions with HAs, clinical development documentation, scientific literature, and content provided by GRPT team members. The PW may be the lead contact for RSW interactions with cross functional teams contributing to the preparation of submission materials, including project and timeline management activities. The PW is responsible for ensuring the accuracy and quality of submission-ready documents using established and effective RSW writing processes. The PW partners with the GRL/Area Lead to prepare high-quality, accurate and concise documentation supporting the objectives of GRPT teams and leadership.
Responsibilities:
- Serve as the RSW lead representative on project teams by partnering with the GRPT including functional area contributors (eg, Clinical, Pharmacovigilance, CPPM, etc.) to prepare a high-quality, clearly-messaged documents founded in regulation and supported by the science.
- Provide leadership and project management expertise for compound programs and/or RSW projects and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Determine and communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Principal Writer is to work closely with GRPT members on the strategic content of target documents.
- Understand, assimilate, and productively interpret info sources with appropriate guidance/direction from GRPT and/or authors/KOLs. Ensure required documentation is obtained. Explain and prepare data in manner consistent with RA requirements. Confirm quality and completeness of info to be presented. Challenge conclusions when necessary. Convert relevant data into a form that meets RA doc requirements. Ensure all RA electronic doc deliverables are processed and compiled in alignment with timelines
- Coordinate the review, approval, QC, and other appropriate functions involved in the production of regulatory projects. Arrange and conduct review meetings with the team. Independently resolve document content issues and questions arising during the writing process.
- Communicate regularly with RSW leadership on timeline/milestone progress for any assigned program. Assess resource needs as timelines progress and communicate any addition resource requests to department management.
- Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
- Proactively identify and implement tactical process improvements.
- Mentor and provide guidance and oversight to support staff including other participating writers and/or external vendor resources and agencies.
This role can be based remotely within the US.
Qualifications
- A Bachelor’s degree is required: Bachelor of Science with significant relevant writing experience, or Bachelor degree in English or communications with significant relevant science experience. A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred, and higher education may compensate for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
- Minimum of 4 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, clinical research, or product support/R&D.
- Minimum of 2 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
- High-level content writing experience and experience with clinical development regulatory documents required, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Advanced knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
- Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology.
- Excellent working knowledge of software programs in Windows environment.
Key Stakeholders
• RA management
• Global Regulatory Product Team members and their associated Regulatory Leads
• R&D functional management and members involved in generating regulatory submission documents
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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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