(Principal) Medical Writer
Boehringer IngelheimShanghaiUpdate time: August 26,2019
Job Description
(Principal) Medical Writer-1911723
Talent@Boehringer Ingelheim
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
- Be responsible for planning, writing, and management of clinical trial reports, submission documents, and other clinical documents.
- Plan and write manuscripts, abstracts, posters and other medical publications.
- Provide critical input to the analysis and interpretation of clinical data.
- Support China to build and lead a team of medical writers, including management and provision of training and coaching.
- Help broaden the scope of the medical writing function within BI and contribute to its development.
- As the lead medical writer on assigned project-level and trial-level tasks, ensures that these assigned medical writing projects are adequately sourced, tracked and prioritized per function needs.
- Write high-quality clinical documents in collaboration with international and national study and project teams. This includes planning, development of document strategies, document coordination, overseeing of timelines, and contribution to related clinical documents (e.g. study protocols, analysis plans, statistical outputs, mock documents, investigator brochures); write medical publications (e.g., manuscripts, abstracts, posters) in collaboration with clinical development/medical affairs experts, key opinion leaders, and other stakeholders.
- Independently writes, manages reviews, and obtains approval of clinical documents including, CTRs (phase I, II, III, and IV), China SGA reports, China Special Review Procedures, China Clinical Overviews, manuscripts, abstracts, posters, and other clinical, regulatory, and medical publications documents.
Ensure timeliness and quality of assigned medical writing projects, using both internal and external resources.
- Supervise and provide training and coaching to team members.
- Develop, adhere to, and improve medical writing standards; ensure compliance.
- Enhance cooperation with other functions and other medical writing groups. Increase awareness and understanding of medical writing and broaden the scope of the medical writing function.
Qualifications
- Education/Degree Requirements: Doctoral Degree (PhD, MD, PharmD) or Bachelor
- Major: Biology, Medicine or Pharmaceutics
- Language skills & proficiency: Good command of English and Mandarin
- Required capabilities (skills, experience, competencies): Excellent scientific and analytical thinking; Basic medical knowledge; Good understanding of statistics and pharmacokinetics; Sound understanding of the clinical development process; Ability to comprehend and interpret clinical data; Ability to lead and motivate people; Excellent communication and interpersonal skills; Excellent writing skills; Ability to write documents according to readers' expectations; Outstanding capacity to structure text and data in a clear and concise fashion; Efficient time and project management skills; Proficiency in word processing and presentation software.
Behaviours
- Accountabilities: Even in ambiguous circumstances, always demonstrate ownership for decisions and actions
- Agility: Quickly act with an open mind to face internal and external transformation
- Intrapreneurship: Together with customers, come up with innovative ideas to respond to changing markets
Contact Us
If you think you can convince us that you are the right candidate we are looking for, apply now!
工作 - 临床运营
主要地点 - Africa, Asia, Australasia-CN-上海-上海
组织 - 勃林格殷格翰（中国）投资有限公司
编制 - 全职
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