The main scope is to ensure compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. Also provides medical expert advice to ensure proper development and promotion of new products. Develops medical product information and stays informed on scientific trends and competition. Maintains relationships with target opinion leaders and trains local teams in medical topics.
Your responsibilities will be:
- Lead Local Medical Affairs TA. Collect, consolidate and communicate trends, market insights, and unmet needs identified in the field to Head of MA TA Region and develop Local TA, Launch and Brand strategies;
- Review Medical and marketing materials and ensure scientific and clinical accuracy. Support the development of Medical marketing materials and trainings. Lead and conduct Local internal training and continuous Medical education. Receives adverse event reports and transmits such reports internally according to Company procedures. Ensures timely completion and up-to-date knowledge of Company policies / SOPs, and local laws and regulations. Maintains up-to-date GxP knowledge by following internal and external trainings. Enforce Regional and Local standards in TA. Responsible for tracking and steering performance of Local TA team along strategy, support efficient resource allocation in TA and collect and share best practices in Local TA;
- Provide Local input into Global Development to support product development. Lead/ support (depending on nature of study) Medical studies, assist to coordinate Local clinical projects and contribute to site selection for clinical projects. Act as a lead and facilitator for ISS and investigators that are aligned to the Medical Affairs strategy. Coordinate with ClinDev and ClinOps in providing field support for research studies and assist in the selection of clinical study sites, as well as support Local publication process;
- Internal Cooperation: Regional Medical Affairs, Regional Strategy and Operations, all other local functions (incl. Drug Safety, Medical information, Quality officer, Market Access and Communication etc.) and Global functions;
- External Cooperation: Local key TA stakeholders in Medical community (incl. external experts, local Medical scientific societies, patient groups, payors), therapy experts and health care professionals (HCPs).
- Impacts the performance of a sizeable area or even the entire sub-function. Sets operational priorities and plans operations. Influences others internally and externally including senior leaders.
- Provides leadership to professional staff or managers to identify and solve (or is responsible for solving of) substantially complex or operationally important problems. Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources, which requires in-depth understanding of how sub-functions work together.
- Accountable for the end results and performance of a sizeable team or multiple related teams. Decisions are guided by resource availability and organizational objectives and business plans. Develops policies. Focuses on performance and results as well as development of area of responsibility. Responsible for day-to-day management, setting objectives, coaching and developing employees, performance appraisal, determining employee compensation as well as the definition of team organization, roles and responsibilities and budget.
Who you are:
- Have Master's degree in life sciences (Bachelor’s), preferably in Physician or scientific field of relevance to position. Secondary /advanced scientific degree (e.g., MSc, PharmD, PhD, DO, MD) required. Scientific and/ or clinical training in area of relevance to position strongly preferred. Other advanced degree (non-scientific) and/or business degree/training is advantageous;
- Have experience in pharmaceutical industry preferred and experience in Medical Department or/and other functions as well as on Global/ Regional level;
- A substantial professional, have clinical or research experience in a scientific or related field required. Knowledge and experience of methodology of clinical research and Good Clinical Practice preferred;
- Have strong network with key stakeholders in multiple TAs is advantageous;
- Have leadership experience with small to medium-sized teams and small budget;
- A professional that should have soft skills such as good communication, strong presentation, computer and analytical skills. He should also have good negotiation, conflict resolution and interpersonal abilities;
- Job specific competencies and skills: Ensure compliance with global and local, external and internal regulations, standards, policies and SOPs. Capture, record and forward any information regarding adverse reactions and /or quality issues to the current responsible LDSO and/ or quality officer;
Para se candidatar a esta vaga cadastre seu currículo no link https://jobs.vibrantm.com/merck/job/S%C3%A3o-Paulo-all-Head-of-MA-TA-General-Medicine-04758-000/530039301/?locale=pt_BR