北京招聘

POSITION SUMMARY:

The Medical Writing Scientist:

-  Learns the medical writing role within the pharmaceutical industry and business.

-  Works in a team environment and matrix.

-  Applies internal standards, regulatory, and publishing guidelines.

-  Proficient in the use of internal systems, tools, and processes.

-  Able to prepare basic documents independently and more complex documents (within the therapeutic area [TA]) (see examples under "principal responsibilities") under supervision. May prepare documents across TAs under close supervision.

-  Able to function as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision.

-  May participate in process working groups.

PRINCIPAL RESPONSIBILITIES:

-  Prepares and finalizes clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, less complex summary documents, RMPs (initial and updates), and less complex regulatory responses. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.

-  Leads cross-functional document planning and review meetings.

-  Works in a team environment with greater independence for longer-term activities, and takes an active role on assigned projects with respect to timing, scheduling, and tracking.

-  Sets their own day-to-day schedule for completing project-related tasks with less supervision and performs more complex tasks and process improvements.

-  Able to guide or train cross-functional team members on processes, best practices; coach or mentor more junior writers.

-  May lead early- or late-stage compound writing teams with close supervision.

-  If a Lead Writer, principal responsibilities include, but are not limited to:

o  Primary point of contact for Clinical/Global Program Team for medical writing activities.

o  Responsible for functional planning (as needed, with management guidance) and metrics database updates for assigned program.

o  Responsible for championing RegMW best practices on assigned program.

DECISION-MAKING AND PROBLEM SOLVING:

Recognizes how to best interpret, summarize and present statistical and medical information to ensure quality and accuracy of content, under supervision.

Responsible for establishing document timelines and strategies in accordance with internal processes, with guidance from functional management and clinical team.

Resolves basic problems independently and more complex problems under close supervision.

ADDITIONAL RESPONSIBILITIES:

1. Regularly meets with manager and mentors, and attends departmental meetings.

2. Attends cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings).

3. Maintains and applies knowledge of industry, company, and regulatory guidelines.

4. Completes all time reporting, training, and metrics database and project tracking (in UCT if lead writer) updates as required.

5. Mentor more junior staff on document planning, processes, content, and provide peer review as needed.

PRINCIPAL RELATIONSHIPS:

Functional Contacts Inside the Company (as collaborator and peer): manager, peer writers. Employees from other departments such as Global Clinical Development Operations, Quantitative Sciences, BioResearch Quality & Compliance; External Alliances; TA staff (Clinical), Regulatory Affairs, GMS, PMO, Clin Pharm, etc.

Contacts Outside the Company: May interact with or oversee the day-to-day work of contractors or external service providers as needed under close supervision. May collaborate with external partner company staff on co-developed compounds under close supervision.

EDUCATION AND EXPERIENCE REQUIREMENTS:

A university/college degree is required .An advanced degree (eg, Masters, PhD, MD) is preferred.?

QUALITIES AND CHARACTERISTICS:

-  Strong oral and written communication skills.

-  Attention to detail.

-  Ability to function and potentially lead in a team environment.

-  Organizes time well.

-  Demonstrates learning agility.

-  Builds solid and productive relationships with cross-functional team members.

-  Basic project management skills.

-  Basic leadership skills (influencing, negotiating, assertiveness, taking initiative).

-  Learns and applies knowledge of regulatory guidance documents such as ICH requirements.

Location：

Beijing，Shanghai

强生是全球具综合性、业务分布范围广的医疗保健企业，业务涉及消费品、制药、医疗器材三大领域，1985年在华创立了***家合资企业。强生遵循企业信条的价值观，致力于践行“关爱全世界,关注每个人”的健康愿景，以领先的科技研发创造创新的理念、产品和服务，为改善人类健康和福祉而不懈努力。每天，强生遍布世界各地的员工，与他们的合作方一起，为全球消费者和病患带来更健康、更快乐、更长寿的生活。
强生于1985年在华创立了***家合资企业。 多年来，强生不断发挥行业领军作用，以创新、高质量的产品和服务，为中国亿万家庭带来健康。如今，强生在中国的业务涉及消费品、制药、医疗器材三大领域，在北京、上海、广州、苏州、西安等90多个城市，拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地，以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业；并通过实现从早期研发到临床应用，致力于加速中国创新产品的研发，促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心，将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构，以及优秀人才的合作，通过提供资金、专业知识和技术，共同将雏形创新转化为医学临床应用的成果，强生并在中国建立全球肺癌研究中心，以满足中国及国际市场的需求，造福病患。
强生心系中国的发展和进步，致力于成为优秀的企业公民。强生积极参与各类重大活动，助力中国的社会经济发展， 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺，强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力，更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐，为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉，充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年，强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜，位列总榜第13名，居全球制药行业榜首。