Medical Writer Head-pharma/CRO
摹根麦肯立人才服务（上海）有限公司
- 公司规模：少于50人
- 公司行业：专业服务(咨询、人力资源、财会) 中介服务
职位信息
- 发布日期：2012-11-09
- 工作地点：上海
- 招聘人数：若干
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：生物工程/生物制药
职位描述
Key Accountabilities
? Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
? Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
? Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
? Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review
Ensure document content and style adheres to SFDA/FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
? Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to PAREXEL guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
? Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
? Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
? Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.
? Attend internal technical team and client team meetings as required.
? Provide training and guidance and act as a mentor to less experienced departmental members.
? Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
? Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
? Assist management as needed in reviewing requests for proposal packages sent by clients to determine content and appropriateness of materials required for development of clinical documents.
? Initiate and participate in departmental or interdepartmental process improvement and training initiatives.
? Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
? Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.
Skills
? Excellent interpersonal, verbal and written communication skills.
? Client focused approach to work.
? A flexible attitude with respect to work assignments and new learning.
? Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
? Willingness to work in a matrix environment and to value the importance of teamwork.
? Team leadership skills.
? Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
? Extensive clinical/scientific writing skills.
If you are interested in the opportunity,you can send me your resume to me via jhuang@morganmckinley.com
? Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
? Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
? Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
? Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review
Ensure document content and style adheres to SFDA/FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
? Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to PAREXEL guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
? Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
? Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
? Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.
? Attend internal technical team and client team meetings as required.
? Provide training and guidance and act as a mentor to less experienced departmental members.
? Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
? Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
? Assist management as needed in reviewing requests for proposal packages sent by clients to determine content and appropriateness of materials required for development of clinical documents.
? Initiate and participate in departmental or interdepartmental process improvement and training initiatives.
? Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
? Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.
Skills
? Excellent interpersonal, verbal and written communication skills.
? Client focused approach to work.
? A flexible attitude with respect to work assignments and new learning.
? Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
? Willingness to work in a matrix environment and to value the importance of teamwork.
? Team leadership skills.
? Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
? Extensive clinical/scientific writing skills.
If you are interested in the opportunity,you can send me your resume to me via jhuang@morganmckinley.com
公司介绍
摹根麦肯立于1995年成立于英国，为英国各知名金融机构提供高标准的求职者，是众多投资银行和金融服务领域大型企业的首选合作伙。2005年，摹根麦肯立由Imprint Plc公司并购。公司合并后，如虎添翼，业务全面发展，是欧洲发展最快的人才服务公司。2008年，摹根麦肯立公司被Premier Group收购。目前摹根麦肯立在英国、欧洲大陆、中东及亚太地区拥有21个办公室，成为全球人才服务领域的领导者。