Position Title：Medical Writing Project Manager/Manager
Department：Clinical Development
Location：Shanghai
Position Summary
Work with medical and clinical physician team to manage clinical study related medical writing activities， and meet customers’ project needs. This role will build and maintain good medical writing relationships across all functionas. With the opportunities to be exposed to a diverse portfolio of clients, this role will also undertake activities involving writing and communication with relevant parties internally and externally.
Key Responsibilities
Conduct and manage medical writing activities
Manage and carry out clinical study related medical writing including IB, study synopsis, protocol, CSR, clinical document translation, etc.
Ensures all final document adheres to SOP, good clinical practice (GCP), and the international conference on harmonization (ICH).
Plan, schedule, review, approve, and track all assigned medical writing activities in close cooperation with the teams to ensure deliverables meet project specification, within timelines to defined quality, and content standards at each point in the document life cycle.
Act as the primary client’s contact for medical writing projects.
Perform literature searches for drafting document content. Interpret literature information and make recommendations for application to clinical regulatory documents.
Search product, target indication with market analysis and report
Work with Quality Assurance throughout clinical regulatory document audit process.
Manage and work on document preparation for regulatory submissions in collaboration with regulatory and BD teams under client specifications.
Assist the training for junior medical writers, may supervise team members as requested
Develop and maintain scientific and clinical trial knowledge, as well as relevant therapeutic areas and medical writing techniques and capabilities.
Lead and conduct any activities involving writing and communication with others, internally and externally, as requested
Education and Key Competency Requirement
Professional Experience & Education Requirement
Minimum Bachelor degree in Medicine, pharmacology, or related life science degrees (or equivalent); Master will be a plus.
4+ years of experience in medical writing or clinical science or equivalent fields in biopharmaceutical or CRO companies, plus solid experience in complex project management or large scale registration trail projects
Key Competency Requirement
Solid knowledge in clinical research process and understand submission requirements
Project management and organizational skills.
Excellent scientific and technical writing skills in both Chinese and English
Proactively seeks out process improvements, efficiencies, and innovations.
Detail oriented to consistency, grammar, syntax, and scientific accuracy for deliverables.
Well-developed of time management, communication, presentation, analytical and interpersonal skills.
To have a detailed knowledge of the regulatory guidance for ICH/GCP
Excellent Chinese and English written and verbal communication skills
Proficient in the use of Word, Excel, PowerPoint, PDF, etc. and applications for medical writing
Customer oriented and proactive working attitude
Self-initiative for continued enhancement of quality, process and skills
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