(Principal) Medical Writer
勃林格殷格翰投资有限公司ShanghaiUpdate time: June 12,2019
Job Description
上海市 静安区

About Boehringer Ingelheim

Join Boehringer Ingelheim and be part of a legacy where your growth is just as important as ours. A global, research-driven pharmaceutical company, we are one of the world’s top 20 leading pharmaceutical companies and havecollaborated and innovated medicines in Human Pharma, Animal Health and Biopharmaceutical everywhere in the world for over 130 years. This is your chance to create ‘Value through Innovation’ with our internal and external partners to improve lives around the world, explore new scientific breakthroughs to stay at the forefront of our industry, and become a leader for future generations.


We continue to grow fast and are one of the top growing companies in the industry in China. Join us and be part of our continued journey to grow and achieve BI global Ambition 2025:

? No. 1 in Animal Health

? No. 1 in Biopharmaceutical Contract Manufacturing

? No. 1 in value share for our brands in One Human Pharma

As a leading company, Boehringer Ingelheim thrives on passion, innovation and independence, and offers fulfilling work and growing opportunities to highly dedicated people. Certified as Top Employer in China in the past 5 continuous years, we help our people grow towards their success through high quality career development programmes and opportunities to lead international projects to develop into a leader of tomorrow. At the end of the day, your growth is our growth and vice versa.


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.


Our innovative medicines include those for COPD, hypertension, stroke, atrial fibrillation-related stroke prevention, Parkinson’s disease, diabetes and non-small cell lung cancer. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients. This vision is supported by industry-leading levels of investment. This includes more than a hundred R&D pipeline projects, around 50% of early- to mid-stage pipeline anchored in external innovation (2016), and around 20% of net revenue invested in R&D (2016) at a global level. Meanwhile, as one of the Company’s strategic pillars in China, Research Beyond Borders (RBB) explores emerging science, indications and technologies to expand R&D opportunities in China, and even the entire Asia.


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
  • 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!

职能类别: 临床数据分析员

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上班地址:上海市静安区南京西路1601号越洋广场29楼

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