Medical Writer, TA Manager
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
- 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.
- 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.
Qualifications :
- Bachelors degree in pharmacy biology chemistry pharmacology or other related academic area or equivalent ability is required. Masters 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 mindset
- Must 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.
Additional Information :
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
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
