1. Related to marketing or other business activities
· Develop medical plan with medical & BU independently.
· Initiate strategic studies of marketed products to come out medical opinion.
· Responsible for publication.
· Initiate strategic portfolio evaluation and provide medical support for business growth.
· Work as internal advisor to MA and marketing.
2. Related to Clinical Development
· Primary contact person for all medical/safety aspects within a given study.
· Protocol/amendment (related to medical sciences) development and finalization.
· Planning, development and execution of Phase 3 and 3B through Phase 4 clinical research, RWE trials, ensuring the clinical program includes a robust holistic evidence package.
· Medical training for entire study team, investigators and CRO staff (if applicable).
· Medical and disease state education, publications, medical information, and medical affairs advisory boards.
3. Related to Regulatory Affairs
· Involved in the preparation for the medical sections of regulatory submissions.
· Prepares the medical section of briefing documents for CDE evaluation meeting, pre-meeting with regulatory authorities.
· Develops scientific reports or responses to study-specific medical issues that may be raised by regulatory agencies.
Who you are:
· Master or advanced degree in clinical medicine.
· At least 2 years multi-national pharmaceutical companies experience in medical.
· Good English at listening, speaking, writing and reading. Able to communicate with global by TC.
· Good communication skills (written and oral) of both scientific and non-scientific information.
· Strong medical knowledge in the therapeutic area.
· Professional knowledge on clinical medicine, metabolism is preferred.
· Knowledge of policies and procedures in Clinical Trials and drug Registration.
· Ability to face challenges.
· Self-learning ability.
Functional Area: Regulatory & Medical Affairs
Job Requisition ID: 206732
Location: Beijing - all
Career Level: A - Current Student
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Job Segment: Medical, Pharmaceutical, Medical Research, Clinical Research, Healthcare, Science, Research