About this role
Purpose Statement:
Prepare high-quality and accurate China-specific regulatory and clinical documents in accordance with regulatory requirements based on policies of global R&D and China Development.Serve as local coordinator to streamline the communication between China project team and global medical writing team (Strategic Medical Writing [SMW]).Liaison activities with medical writing vendor as needed regarding preparation of regulatory and clinical documents.
Major Responsibilities:
Take a leading role , including, but not limited to, confirming the scope of the task, confirming templates and specifications, working out and tracking timelines, collecting cross-functional inputs, organizing document reviews and obtaining final approval in preparing assigned China-specific CTA- and NDA-related documents (esp., CDE consultation briefing book and slides, justifications, responses to CDE inquires, China-specific Clinical Overview, breakthrough and priority review applications, etc.) in accordance with pharmaceutical regulations, SOPs, manuals, etc.Lead or support the preparation of China standalone study relevant clinical documents (Clinical Study Blueprint, protocol, amendment, CSR, etc.) for assigned project.Act as local coordinator to streamline the process of collecting the inputs from China project team and to strengthen communication between China project team and SMW during the development of documents (protocol, amendment, CSR, etc.) led by SMW project medical writer.Conduct liaison activities with medical writing vendor regarding preparation of regulatory and clinical documents.Cooperate with key stakeholders (RA, global medical writer, China project leader, etc.) in the formulation of strategies for preparation of regulatory or clinical documents of the project in charge.Build cooperative relationships with stakeholders in SMW and assigned China project team.Ensure that appropriate quality control (QC) checks are performed on medical writing deliverables, as required. Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master’s or PhD/MD degree is preferred.At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including at least 2 years’ experience in medical writing.Ability to communicate clinical data succinctly, clearly, and accurately in writing.A good team player and good planner with proactive, accountable, and details-oriented mindsetMust have excellent fluency in both oral and written communication skills in both Chinese and English.Excellent skill for operating Microsoft Office (Word, Excel) and Adobe Acrobat is preferred. 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.
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