Principal Medical Writer
YOUR TASKS AND RESPONSIBILITIES:
- Independently authors study level clinical documents and individual clinical submission documents and implements the submission authoring strategy under the leadership of Senior Principal Medical Writer
- Drives the design of all assigned study level and project level clinical documents in support of the Global Clinical Operations Roadmap under the leadership of Senior Principal Medical Writer
- Validates the individual study protocol design and key messages in clinical study report
- Contributes to the project level data presentation strategy and messaging standards under the leadership of Senior Principal Medical Writer
- Mentors Senior Medical Writers and Medical Writers (internal and insourced) in developing expertise in writing submission documents
WHO YOU ARE:
- University degree or above
- Should have at least 5 years experience in regulatory medical writing with experience in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.)
- Must have experience in the pharmaceutical industry whether it be directly with a pharmaceutical company or at a CRO
- Prefer someone with good leadership and people management skills and great interpersonal skills
- Must have experience in developing clinical documents in support of regulatory submissions globally (i.e., multiple regions)
- Must have an in depth understanding of all regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, PMDA, FDA, EMEA)
- Must have a thorough understanding of the overall drug development process. Specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions is required
- Experience in supporting diverse therapeutic areas is preferred
- Must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions
- Must demonstrate strong communication skills in English and Japanese, both written and verbal required to articulate concepts and ideas
- The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Pharma Research & Development organization
WHAT BAYER CAN OFFER YOU:
- We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at Bayer
- We provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your manager
- We support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participations
- At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employees
- We provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance
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