The Medical Affairs Associate will manage various medical affairs projects, focusing on RMP deliverables, documentation, and coordinating RWE projects, as well as overseeing operational strategies and budget management.
This role requires candidate with previous pharmaceutical operational experience, project management experience, demonstrated agility, and communication skills.
The role will be various medical affairs projects assigned by the medical director such as managing medical financials, assist in cross functional communications.
Be accountable for RMP deliverables and assigned RWE projects:
-RMP, candidate will need to consolidate and draft RMP documentation required by the health authorities for assigned Pfizer products. This also includes reviewing and insuring requirements for RMP documents are provided by cross functional teams.
- RWE, the candiate need to co-ordinate efforts of assigned new or ongoing RWE projects and to manage study issues and compliance with standard processes, policies and procedures. Ensuring and track budget spending match study milestones. Liaise with above country functions to insure study milestones adhere to Pfizer policies and are properly documented
Basic Qualifications
Preferred Qualifications
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
The role will be various medical affairs projects assigned by the medical director such as managing medical financials, assist in cross functional communications.
Be accountable for RMP deliverables and assigned RWE projects:
-RMP, candidate will need to consolidate and draft RMP documentation required by the health authorities for assigned Pfizer products. This also includes reviewing and insuring requirements for RMP documents are provided by cross functional teams.
- Health Authorities Committments: Consolidate, Review, RMP commitment from various cross functional sources
- Narrative Writing: Write clear, concise case narratives summarizing adverse events for health authority submissions.
- RWE, the candiate need to co-ordinate efforts of assigned new or ongoing RWE projects and to manage study issues and compliance with standard processes, policies and procedures. Ensuring and track budget spending match study milestones. Liaise with above country functions to insure study milestones adhere to Pfizer policies and are properly documented
- Managing the internal process in Pfizer system of medical projects, including but not limited to clinical research of secondary database analysis study, non-interventional study, low-interventional study, pragmatic trials, advisory board, publication ...etc.
- Scope of work includes operational strategy, vendor communication, project timeline and milestone oversight, budget monitor, project documentation, publication quality control, and project closure to comply with internal and external operational requirement.
- Other medical affairs projects appointed by supervisor.
- Align with project owner on budget planning, allocation & phasing, tracking & monitor, managing project amendment or deviation requirement; align in and above country medical financial operation.
Basic Qualifications
- Advanced degree in the medical sciences or related discipline.
- Basic experience in clinical research, and/or study management across a range of therapeutic areas
Preferred Qualifications
- 2+ years' experience in the pharmaceutical industry
- Experience in managing finance
- Experience in RMP documentation preparation
- Pharmacist or related degree
- Extensive knowledge in study operational processes.
- Good documentation skills
- Good English verbal and written communications skills
- Audit experience
- With a pharmaceutical or CRO background.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
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