Principal Strategic Medical Writer
关于 AbbVie,阿伯维的使命是发现和提供创新药物和解决方案，以解决今天严重的健康问题并应对明天的医疗挑战。我们努力在包括免疫学，肿肿瘤学和神经科学等几个关键治疗领域以及我们的艾尔格安美术产品和服务中对人们的生活产生显著影响。有关 AbbVee 的更多信息请访问 www.abbvie.com. @abbvie 在 LinkedIn,Facebook,Instagram,X 和 YouTube 上。主要战略医学作家负责领导和撰写支持公司目标的药物和/或设备开发的临床和监管文件。负责：· 自主编制用于 AbbVIe 药品和/或设备开发所需的大多数临床和监管文件。·协调审查，批准和对其他参与临床和法规文档生产的功能质量控制。与团队安排并进行审查会议。与团隊密切合作) 在文档撰写和内容策略上。·向团队成员传达必要的交付成果，书面过程和时间表。· 让团队成员承担协议定的项目日期的责任。· 贡献项目管理战略，发展领导团队成员，提交目标的能力。· 建议，领导和/或参与实施/执行战术过程改进。· 在编写监管文档期间出现的问题和问题解决方案的确定和提出建议。· 学习并将治疗领域和产品知识应用于科学项目和业务改进项目的独立工作。· 与研发质量保证合作，以处理查询和草案回复，保持准备检验方法。· 提供药物/疗法在各种治疗领域的广泛市场中的全球制药，生物技术，生命科学或医疗保健机构中至少有5年以上生物制药行业经验。需要学士学位或更高水平；优先考虑科学纪律。·卓越的书面和口头沟通技能，具有多个治疗领域的医学和科学术语综合知识。·熟练于
查看英文原文
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.
Responsibilities:
· Independently prepares most clinical and regulatory documents needed for the development of AbbVIe drugs and/or devices.
· 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 US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
· Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
· Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects.
· Works independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.
- A minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas.
Bachelor's Degree or higher required; scientific discipline preferred.
· 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 and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines. EU and US device writing experience is a plus.
· 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 communicates 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.
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 thisposting 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 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 anduntil 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