Sr Mgr Biostatistics jobs at Teva in Mexico

Provide marketing and commercial end-to-end leadership for relevant TA to develop and implement a strategic approach addressing key unmet needs, generation brand equity, channels and pricing strategy, TA knowledge and market understanding boosting corporate objectives to develop and generate value to our stakeholders.

To internal stakeholders, this role acts as a reference point for the assigned therapeutic area. This may include activities like:

• Fully accountable for Sell Out through demand generation
• Brand / TA equity generation
• Brand planning and QBR (this includes market data understanding: PMM, ATV, CUP, Veeva etc)
• Launching process (this includes strategic approach to full TA)
• Supply planning
• Budget accountable
• Field work
• Comply with trainings and compliance procedures
• Field visits to obtain relevant feedback from sales team
• Partnering access teams for strategic selling
• Build relevant network with peers from other countries

To external stakeholders, this role acts as a reference point for the assigned therapeutic area. This may include activities like:

• Field visits to other relevant stakeholders
• Organizing and executing engagement activities according to TA / Brand strategy
• Relevant engagement plans with scientific organizations and professional groups
• Represent Teva in relevant meetings

Education: Bachelor or Licensed professional of healthcare sciences, marketing, administration, industrial engineering or communications

Experience: 5+ years of pharmaceutical industry experience, preferably with 3+ year(s) experience in Marketing teams (it is a must Rx segment). Experienced at working collaboratively in an autonomous way. Expertise in current TA is a plus

Language Requirements: English Fluent

Country General Manager

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This position will be responsible for several site wide EHS programs and processes to safeguard employees and surrounding communities and to ensure that all facilities are in compliance with regulations. Responsibilities are within the EHS function as a generalist or in a combination of disciplines.

TRAVEL REQUIREMENTS:

• Uses best practices and knowledge of internal or external business issues to improve products/services or processes
• Often leads the work of project teams
• Requires in-depth knowledge and experience in general safety, occupational health and environmental regulations
• Solves complex problems independently; takes a new perspective using existing solutions
• Works independently; receives minimal guidance
• EHS training presentation skills
• Assists in emergency response and preparedness 24/7
• Responsible for OHSA related Programs
• Responsible for the occupational health programs including:
o Industrial hygiene
o Medical surveillance
o Hearing conservation
o Chemical management program
o Process containment
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires Bachelor’s degree in Science, Engineering or equivalent from an accredited college or university and a minimum of 3-5 years relevant progressive experience in the pharmaceutical industry.
• Requires a minimum of 7 year of experience in an environmental or safety and regulatory compliance experience, preferably in food, drug or cosmetic industry.
• CIH or CSP preferred
• Requires experience with Federal, state, and local regulations relative to environment, health, and safety (OSHA, EPA, FL DEP, etc.).
o General Safety
o Occupational Safety
o Process Safety
o Environmental Regulation
• Knowledge of Current Good Manufacturing Practices (cGMP) a plus

Skills/Knowledge/Abilities:
• Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Writing, preparing and presenting safety related regulatory programs.
• Preparing clear and concise reports and/or proposals related to safety and regulatory compliance programs.
• Communicating clearly and concisely, both orally and in writing, with all levels personnel.
• Establishing and maintaining cooperative working relationships with those contacted in the course of work.
• Operating a personal computer, including working knowledge of Microsoft Office.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
• Developing and delivering training of all levels of personnel in the areas of safety and regulatory compliance.
• Self-starter; Results driven; Anticipate/initiates and implements solutions.
• Adheres to professional standards and company code of conduct.
• Must be comfortable in a fast paced environment
• Ability for scheduling flexibility to cover different work shifts (24 hours a day/7 days a week).
• Required to be on call 24 hours for emergency response needs.
• Training and presentation skills, techniques, applications and practices.

Problem Solving:
• Analyzing problems, identifying alternative solutions, and implementing recommendations in support of Company safety goals and objectives.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Ensure pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products.
• Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving.
• Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.
• Support team members with complex issues as a senior expert (especially in responsibilities 2–6).
• Lead a team of academic staff and administrative staff handling EU Labeling and support departmental leadership.

1. Department Leadership
• Organize and coordinate departmental tasks, personnel management, and planning.
• Manage budget and resource planning.
• Establish efficient internal and cross-departmental processes.
• Lead projects related to labeling, including project management.
• Review and approve SOPs for the department and overall processes.
• Support division leadership and develop strategy, principles, and guidelines.
2. Team Leadership
• Organize and coordinate team tasks, personnel management and planning.
• Plan team activities and align with other teams.
3. Labeling
• Responsible for creating and updating compliant English product information for EU procedures.
• Strategic planning and implementation of changes affecting multiple product information documents.
• Determination of an implementation plan and tracking the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update)
• Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings).
• Discussion of the content of product information for innovative products (pre- and post-approval) in project teams.
• Evaluate and approve change requests; coordinate submissions with EU regulatory units.
• Collaborate on patent-related issues with Global IP Group.
• Contribute to readability studies and ensure PIL readability and compliance with legal requirements.
• Adaption to reference medicinal product (generic, hybrid, biosimilar procedures).
• Preparation of Expert statements (justification) for type II variations.
• Providing scope of variation to regulatory affairs.
• Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates.
4. Monitoring
• Monthly monitoring and communicating safety updates from EU authority websites.
• Track reference product updates and legal/guidance changes affecting product information.
5. Pharmacovigilance
• Assess need for updates based on Company Core Safety Information (CCSI).
• Implement PV-triggered and non-PV-triggered safety updates (e.g. PRAC/PSUSA/PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA.
• Participation in Product Safety Group (PSG) Meetings.
• Implementation of internal signals (including determining PIL wording).
6. Scientific Work & Authority Communication
• Participate in project teams to fix the regulatory strategy and prepare expert statements.
• Respond to authority deficiency letters in collaboration with other departments.
7. Mock-ups
• Coordinate creation and approval of packaging mock-ups, Braille, and specimens.
• Address authority queries and ensure compliance with EU regulations.
8. Industry Representation

• • Participate in working groups (e.g., Medicines for Europe) to represent the company as an EU labeling expert.

• Experience: 12+ years of total experience and minimum 8 years in relevant fields (medicinal information and EU labeling in the pharmaceutical industry), ideally in Regulatory Affairs with at least 3 years of leadership experience.
• Education: Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry), preferably with a Ph.D. Additional leadership qualification is preferred.
• Other: Advanced English (spoken and written), strong MS Office skills, excellent knowledge of EU pharmaceutical law, regulatory affairs, and related legal areas. Project management experience required.

• Partner with people managers to drive people strategy in a small BU or function (HRM role)
• To serve as a TR expert at country and cluster level, to give advice and train TR local focal points and HRMs and to be a bridge with the Global TR team..
• To be the focal point for the TR Survey in Latam, advise best practices of the rewards programs and provide assistance where needed. To influence, coordinate and lead TR activities and TR programs implementation in LatAm.
• To support leaders to manage employee relations and drive people strategy in a small BU or country.

Academic Background: University Degree

Experience:7+ years of experience and 3 of them in Total Rewards in multicultural and matrix companies.

Advanced English is a must.

Competences:

• Leadership
• Communication
• Self Driven
• Interpersonal Skills
• Strategic and critical thinking

Sr Director HR Latam

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

To be primarily responsible for executing sourcing strategies for Latam HUB organization for Sales&MTK, HR, IT & Communications, Corporate and Professional Services. Provide support to the main North America procurement contact for Facilities, MG&S (Utilities&Waste, Security and Laboratory) categories.

Part of the Procurement Americas HUB, for regional and local negotiations.

Responsible for implementing the global strategies on the sites within Americas HUB.

Follow and report internal processes for new suppliers.

Demand Management: Ensure that the business requirements of all key stakeholders and scopes of work are well understood and accurately covered in the sourcing process. Influence business demand where required and possible.

Sourcing Strategy: Develop sourcing strategies in accordance with the respective category strategy. Define approach to market and develop source selection criteria based on the business priorities and requirement.

Develops risk management strategies and recommends short- and long-term initiatives with defined risks/benefits.

Update and maintenance of savings (CR and CA) into WAVE system.

Academic Background:

Experience:7+ years in Procurement Sourcing with experience in indirect categories. Demonstrated excellence in preparation and execution of sourcing strategies, management of Requests for Proposals (RFPs), supplier selection methods and negotiations. Background in the Pharma and/or Chemical Pharmaceutical industries strongly preferred.

Experience with Sourcing/Procurement tools and methodologies, RFI, RFP, RFQ, bids evaluations, cost models, strong negotiation skills for pre and post contract awards. Experience in regional positions.

Analytical skills and a results-oriented approach.

Technical Knowledge:MS office skilled, ERP: Ariba S2C modules, and SAP preferred.

Advanced English and Spanish

Assoc Dir Cntry Procurement Head

DIRECT REGIONAL PROCUREMENT - MX

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Primarily works at the Product/Program Level
• Provide input for budget planning
• Manage and Deliver assignments with quality and within timelines
• Possible to have direct reports; Possible to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources
• Responsible for statistical aspect of study designs and data analyses for clinical studies
• Provides study design input and consultation for clinical endpoint assessments and sample size planning
• Prepares, or oversees the preparation of statistical sections of clinical protocols in collaboration with key stakeholders, as deemed necessary
• Writes, or oversees the writing of, statistical analysis plans
• Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts, and other documents to support the marketing of Teva products
• Leads the conduct of analyses and document preparation to support global regulatory submissions, including briefing packages, integrated analyses, and regulatory responses.
• Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate
• Proactively assesses and identifies processes that require improvement
• Participates in department initiatives to further the effectiveness of global statistics
• Implements innovative and cutting-edge clinical trial design, methodology and analysis

• Ph.D./MS in Statistics/Biostatistics (or related field)
• MS with a minimum of 10 years of related experience; PhD with a minimum of 6 years of related experience
• Proficiency in statistical programming languages (e.g., R, SAS) and experience with data visualization tools
• Regression modelling, Simulation, Adaptive trial designs, Bayesian statistics, Experimental design

The Regulatory Affairs Manager will ensure compliance with national and international regulations, managing submissions and keeping product records up to date throughout the product's life cycle.

• Manage the regulatory submissions to local authorities (new applications, lifecycle management, licenses, GMPs).
• Guarantee compliance with applicable national and international regulations.
• Review regulatory changes assessing their impact on company operations and train the applicable areas.
• Monitor responses to regulatory inquiries and resolve pending issues.
• Keep update internal databases and applicable software to perform regulatory tracking and intelligence reports.

Required Education: Bachelor's degree in QFB, QFI, IQ, LQ or related career, preferably with a higher academic degree.
Experience: Minimum 3 years in similar position in regulatory affairs or related field.
General knowledge in Quality Management Systems, management skills, training as an auditor.
Specific knowledge of national and international regulatory standards (ICH) applicable to the pharmaceutical industry (LGS, RIS, NOM, etc.), Food Supplements, Medical Devices and Cosmetics.

Sr Mgr Regulatory Affairs

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.