Medical Manager - Genitourinary Oncology
MAIN RESPONSIBILITIES / DUTIES
MEDICAL:
Provides support and the necessary medical and scientific information of reputed company Biopharmaceutical Group products to reputed company customers assuring compliance with Corporate and Local Procedures and applicable regulations providing full support to our local medical objectives.
Collaborates with Drug Safety Unit, Global/Regional Therapeutic Areas and Regulatory Affairs in preparation of the reputed company Management Plan of the products under her/his responsibility.
Collaborates with Regulatory Affairs to review and assess the Local Language Document of the products under his/her responsibility
Management of the whole process of the reputed company and Research Collaborations and Local and Regional Non- Interventional / Interventional Studies (different from BE studies) as per the applicable reputed company processes, and to the therapeutic area under his/her responsibility following major milestones and budget.
reputed company guidance with regards to do´s and don’ts to reputed company colleagues, be role model with regards to Compliance.
· Be the official spokesperson with MD for their portfolio of products to reputed company authorities.
Supports MSLs coaching.
reputed company and maintain reputed company relationships with KOLs, Medical Societies and reputed company centers to partner in CME reputed company.
Manage Medical Affairs annual budget as reputed company.
reputed company the Medical Affairs annual local plan, reputed company to reputed company objective(s), and coordinate derived tactics.
Assure Medical Affairs plan execution with the collaboration of the MSL.
reputed company RESEARCH
Together with the cross functional team identify and reputed company the scientific question and determine the need to conduct locally sponsored reputed company (e.g., phase IV reputed company, epidemiological, Pharmacoeconomics, reputed company etc.) to support the strategies of the assigned reputed company products.
Responsible of the locally sponsored reputed company, proposing investigators, site identification, coordinates investigators´ meeting and once the reputed company trial is ongoing will continue to have reputed company contact with investigators and the medical reputed company of the trial. Manage timelines and budget ensuring that information reputed company to the protocols is sustained in reputed company Corporate reputed company Registry systems.
Management of the whole process of the reputed company and Research Collaborations and Local /Regional Non- Interventional / Interventional Studies (different from BE studies) and compassionate reputed company programs until their completion to assure adherence to reputed company requirements and local regulations.
Collaborates with Drug Safety Unit, Global/Regional Therapeutic Areas and Regulatory Affairs in preparation of the reputed company Management Plan along with the conduct of reputed company Post Authorization Safety Studies (PASS) conducted because of a commitment to the MoHas a condition of marketing approval.
reputed company the publication strategies of local reputed company and epidemiological trials in adherence to the reputed company requirements.
Participate before, during, and after audits and inspections reputed company required and during the implementation of the Corrective reputed company/Preventive reputed company (CAPA) of the reputed company studies under his or her responsibility.
MARKETING
Full involvement in providing scientific and medical inputs during the setup of new products, working together with Business Analytics and Insights area.
Collaborates during product launch process, including his/her participation in reputed company Planning/New Product meetings.
Collaborates with CBL/CPL in designing marketing campaigns, providing medical and scientific knowledge during the development of Promotional Materials and/or activities of reputed company products for the assigned therapeutic area.
Reviews and validates scientific contents of the activities sponsored by Marketing and Customer Engagement Programs together with the CBL/CPL.
Maintains reputed company communication with Medical Associations, Ministry of Health and reputed company Institutions for reputed company regarding Medical and Marketing Areas, including reputed company Medical Education Programs.
Develops with Key Opinion Leaders material for scientific presentations of the products reputed company.
Collaborate in the training of their portfolio of products under their responsibility.
Coordinates Medical aspects of scientific events (educational and/or promotional), selecting speakers and assuring ethics and scientific content (Communication management to Sales Force, Media, and Opinion Leaders) for reputed company Medical Education Programs.
Train the trainers and their reputed company colleagues on product and disease knowledge of their portfolio of products. Validate training materials.
Maintains reputed company communicationwith Regional Team members of reputed company products for the assigned therapeutic area, reputed company participating in teleconferences and in the annual meetings of MM/PP (Medical Managers/Product Physician meeting).
Provides input, feedback, and collaborates in Market Research activities as needed.
Provides medical and scientific support to the Corporate Affairs area in relation to reputed company dissemination of reputed company products for the assigned therapeutic area.
reputed company participates in POA and reputed company-POA business meetings and other medical training.
reputed company participates in authoring or reviewing medical papers.
Strategically coordinates, develops and implements Advisory Boards and speaker training with reputed company reputed company on business needs.
Periodic reputed company work activities /reputed company with physicians now in separate sessions from Sales Representatives.
REGULATORY
Reviews/validates and approves the updated Local Product Documents (LPDs) and Package Inserts of assigned products in accordance with the corporate information and with Local Regulatory requirements.
Supports the Regulatory Affairs Department during the process of product registration in the country, including preparation of meetings with the Regulatory Authorities.
Prepares the Medical and Scientific information that will be submitted to national, local, and private/reputed company for formularies and listings.
Coordinates the preparation of Medical and Scientific reputed company to include new therapeutic indications, formulations, and second and reputed company brands together with the Regulatory Affairs and Medical information Departments, guaranteeing that the Product Information is consistent with the LPD (Local Product Document), International Product Information, reputed company Product Characteristics, reputed company Product Information (reputed company); as reputed company as in adherence with the reputed company SOPs and Local Regulations.
MEDICAL INFORMATION AND PHARMACOVIGILANCE
Follow up with the Drug Safety Unit on any topic about Adverse Events (Spontaneous and/or reputed company reputed company) that may require his/her medical support.
reputed company interaction with Medical Information supporting dossiers and promotional material needs.
reputed company STANDARDS
Complies with the Training Curricula.
Attend reputed company the required training meetings according to established timelines.
Knowledge and full participation on the Inspection Readiness Process and the applicable procedures before, during and after corporate audits or regulatory inspections.
REQUIRED reputed company SET
Technical
Technically updated in local regulations
reputed company in English (both written and spoken)
Ability to prepare presentations and reputed company reputed company speeches
Ability to teach and train
Abilities in negotiation and effective communication
Excellent abilities in reputed company and interpersonal influence
Knowledge of scientific, ethical, regulatory and reputed company aspects which allow the conduction of research trials in reputed company beings
Handle computer software, specifically reputed company Office, internet and other basic electronic tools
Business and Financial acumen (budget management)
Managerial
Leadership:
Maintain reputed company on reputed company
Contribute to an inclusive atmosphere
Encourage reputed company discussion and debate
Handle change
reputed company his/her colleagues
Alignment through reputed company
Organizational:
reputed company
Innovation
Respect reputed company
Customers reputed company oriented
Teamwork
Leadership
reputed company
Community
Functionality:
reputed company thinking
Analytical thinking
Good planning and organization
Judgment for decision-making
Initiative
reputed company on business
Set priorities
Good communication
Teamwork
Leadership
reputed company on results
reputed company of urgency
Business travel
Certifications
A minimum of 3 years’ experience in positions reputed company reputed company reputed company or linked with medical affairs, R&D, medical-marketing, marketing, reputed company research or medical direction, preferably reputed company the pharmaceutical industry.
Education
Medical knowledge in the assigned medical area of the products reputed company.
Medical degree required: preferably specialty
Experience
Experience in project & budget administration and management.
EEO (Equal Employment Opportunity) & Employment Eligibility
reputed company is committed to equal opportunity in the terms and conditions of employment for reputed company and job applicants without reputed company to race, reputed company, religion, sex, sexual orientation, age, gender identity or gender reputed company, national reputed company, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on reputed company Careers.
MedicalOriginally posted on Himalayas
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