Director Clinical Development - Respiratory jobs at Teva

This position is responsible for the oversight of the site Environmental, Health and Safety Program to ensure compliance with all federal and state EPA, OSHA and DOT regulations. This position oversees internal and external audits, risk analysis, hazard assessments, etc. This position also develops and implements programs to support safety culture.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for ensuring compliance with federal and state regulatory requirements.
• Responsible for the facilitation of recognition, evaluation and control of environmental and occupational hazards.
• Responsible for ensuring compliance with all EH&S documentation such as OSHA 300 log, environmental permits, DOT shipping documents and training.
• Responsible for the oversight of internal environmental, health and safety audits to identify actual or potential hazards, institute corrective measures and follow up to ensure consistency.
• Respond to product safety requests for experimental & commercial materials including EH&S technology transfers, SDS’s, development and toxicity testing.
• Responsible for advising senior staff regarding current regulatory requirements and status, and pending legislation that may affect the business.
• Responsible for completing all training requirements and maintaining 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 an undergraduate degree or equivalent with a minimum of 10 year’s progressively relevant experience in a manufacturing environment.
• Requires understanding of federal and state requirements for environmental health and safety or related area(s) and controlled substances handling or related area(s).
• Requires knowledge of pharmaceutical manufacturing operations and lab procedures.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments, business units and external partners.
• Ability to demonstrate sound judgment and decision making.
• Ability to identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to analyze information and create metrics relevant to the business objectives.
• Project management and advanced presentation skills preferred.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct method and procedure for problem resolution.

Travel Requirements: Up to 10%

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.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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.

Embark on a future with an international pharmaceuticals company, contributing your creative energy to high-impact projects from the moment you arrive through the course of this 12-week experience. You will take part in meaningful work and real-life projects that will help you grow both professionally and personally throughout the program.

• Location: West Chester, PA 19380
• Length: minimum of 12 weeks (TBD during mid-May through mid-August)
• Schedule: You must be available to work a 40-hour work week for 12 weeks
• Pay: TBD

Tasks & responsibilities

• During the 12 week program, you will gain in-depth insight into the Drug Product Development department.
• Learn and apply High Throughput Experimentation (HTE) strategies and equipment
• Explore and develop new formulation technologies
• Gain hands-on experience with dynamic light scattering (DLS), static light scattering (SLS), and full spectrum fluorescence (FSF) to study the colloidal and conformational stability of antibodies
• Learn how to plan and execute scientific experiments: prepare samples, perform testing, record results in electronic notebook, analyze data, prepare final presentation.

Qualifications

• Currently enrolled in an undergraduate program of Chemistry, Biochemistry, or related field
• Prior lab experience is preferred.

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.

The director of gross to net forecasting will be responsible for business partnering with cross functional teams including value & access, patient services, demand forecasting, revenue accounting, pricing and brand finance to develop gross to net forecasts for specific Innovative Medicines or Biosimilar products. In this role you will own and manage the forecasting assumptions, pressure test and challenge inputs from other areas, understand the business rationale and market events that shape and impact the gross to net forecast. You will also contribute to driving reporting enhancements, process improvements and value added deal modeling analysis where necessary.

• Learn and understand the gross to net process currently deployed including the various inputs, outputs, interdependencies and how specific changes may trigger impacts to other areas
• Develop and produce quarterly gross to net forecasts to meet internal planning timelines and deliverables with meaningful and insightful explanations on drivers of change vs prior forecasts and/or AOP (annual operating plan) and LRP (long range planning)
• Coordinate with demand forecasting, Value & Access and brand finance on events that impact the gross to net rates and the channel mix for products taking full ownership and accountability for reflecting impacts in the gross to net forecast
• Monitor and track claims data for Commercial, Medical Commercial, Medicaid, Medicare, 340B and other government segments to changes to business mix and impacts to the brand gross to net rates
• Perform quarterly actuals reporting with variance analysis to forecast, prior quarter and/or AOP with meaningful explanations
• Work closely with revenue optimization and controls compliance group on rebate scrubbing to determine impacts to minimize revenue leakage
• Develop and provide perspective and thought leadership on respective brands to help drive decisions and meet or exceed financial targets
• Support Biosimilar and Innovative brand launch strategy through scenario planning and modeling
• Ad hoc analysis as needed related to related to but not limited to contract proposals, developing views and analysis to help and inform business decisions, inform and educate business partners on gross to net implications and changes to programs and/or policies

• Bachelor’s degree in Business, Finance, or related discipline required (or higher)
• Minimum of 5 years of increased levels of responsibility in progressive gross to net forecasting roles
• Strong working knowledge and modeling of gross to net forecasting including understanding various payer channels (Commercial, Medical commercial, Medicare, Medicaid, PHS340b, VA/DoD, Tricare, etc.)
• Working knowledge of payer contracting strategies and deal modeling
• Proven business acumen in forecasting (demand, sales, gross to net) with data driven analytical work to support assumptions and perspective
• Very comfortable with large data sets, sorting, filtering, trending, charting and graphing functions in Excel and PowerPoint
• Clear / concise communication and interpersonal skills with ability to effectively explain complex topics to business partners with and without gross to net acumen
• Agile team player; able to adapt and execute based on evolving business needs, with strong active listening skills
• Working knowledge of Alteryx preferred but not required

The annual starting salary for this position is between $158,000 – $198,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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.

The Director, in Global Regulatory Medical Writing, may write and edit clinical regulatory documents, including submission summaries and other complex documents, provides a significant level of oversight and expert guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. The Director offers clear leadership and extensive accountability, strategic vision, and planning for clinical regulatory documents.

: International and domestic

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Primarily works on the therapeutic area/functional level
• Likely to have direct reports; oversees contingent workers and/or vendors; provides training to others; strategically analyzes needs to manage resources and is accountable for resource allocation
• Oversees/mentors for all document types
• May write and edit clinical regulatory documents (all types)
• Ensures that documents include the proper context and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
• Leads/recommends the preparation/revision of document templates
• Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
• Responsible for tracking/providing metrics and established key performance indicators

• PhD/PharmD with a minimum 8 years experience or a Master’s with a mnimum of 10 years experience
• Mastery of Microsoft Word
• Advanced regulatory medical writing expertise, strong writing/editing skills, knowledge of drug development regulations
• Global regulations and guidelines for document submissions

The annual starting salary for this position is between $177,680 - $233,205 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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.

• Technical/functional knowledge in Accounting and reporting process area
• Ensuring that accruals are properly recorded and analyzed
• Preparation of Journal Entries & Supporting schedule
• Supporting monthly and quarterly activities of multiple entities
• Analysis of the various accounts and variances per legal entities, obtain explanation on deviations and prepare a summarized reporting on a monthly basis within scheduled time
• Preparation and review of account reconciliations
• Overall understanding of how processes within Financial Reporting area influences system feeds and final reports
• Supporting standardization of processes and tasks across the team
• Acting as a key contact for local and global teams for record-to-report related questions
• Ensuring that accounting books and records comply with accounting policies and regulations
• Providing supporting documents and explanations for all internal and external audits as and when required
• Participating in ad-hoc projects

• University education in Accounting or Finance required
• Minimum 3 years of experience in accounting and/or auditing
• Preferably familiar with US GAAP
• Good knowledge of Sarbanes Oxley Act and/or internal control concepts
• Good working knowledge of SAP or any other ERPs
• Good understanding of accounting and reporting processes
• Good analytical skills
• Fluent verbal and written communication in English, other language is a plus
• Experience in a multinational firm or within a shared service center is preferred
• Hands-on and proactive; strong organizational skills
• Accustomed to working with deadlines, in a dynamic environment
• Results driven and service-oriented to internal and external customers
• Excellent collaboration with colleagues within the local organization and with the colleagues of the global business service to support the overall Finance department’s goals and objectives
• Flexible and able to work in a changing environment
• Strong focus on improvement opportunities
• Want to work in a new established team

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.

Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate

• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
• Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
• Collaborate with scientific personnel for planning, preparation and publishing
• Maintain working knowledge of internal and external publishing standards.
• Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

• B. Pharm/M. Pharm/ Master of Life Sciences.
• Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
• Command over spoken and written English
• Sensitivity to the cultural diversity of a global organization
• Good understanding of regulatory IT systems

Manager – Regulatory Submission Management

The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.

• This second line leadership role will develop and coach Managers and Senior Managers on the strategic sales vision and executional expectations for the teams for which they have responsibility, ensuring alignment to organizational strategy
• Accelerate sales performance within the assigned market, including sales and market initiatives, and the development of people
• Lead and oversee all market initiatives to completion, leveraging and aligning internal Teva commercial resources to ensure initiatives meet customer needs and optimize the customer experience
• Develop, implement, and execute strategic plans to achieve revenue targets and market share goals within the assigned market
• Analyze market trends, competitor activities, and customer feedback to make informed decisions and adjustments to the business strategy
• Align all sales performance and market initiatives to key selling and business strategies of Teva
• Measure sales performance and market initiatives by establishing key performance indicators (KPIs) and regularly monitoring and reporting on your area’s performance to senior management
• Develop and execute communication plans at the area level that drive accountability, recognition, and clarity on strategic direction
• Build rapport and relationships by interacting effectively with area team members, cross-functional partners, healthcare professionals, key opinion leaders, and stakeholders, demonstrating the awareness of their needs and responding with the appropriate action
• Maintain a competitive edge by effectively addressing external market challenges while fostering a collaborative environment with internal teams to drive cohesive and successful sales strategies
• Create market access pull through plans and executional oversight of these plans to increase the knowledge and focus of the assigned area
• Develop, implement, review, and revise effective business plans to meet and exceed area and national sales goals
• Provide leadership and coaching to regional managers on the development and implementation of effective business planning
• Coordinate with internal customers to conduct risk assessments and identify and maintain beneficial relationships with internal and external customers
• Instill within the assigned area a culture of continuous improvement and development of the Sales team
• Lead annual Talent Review process to identify and develop high potential future leaders as well as identify potential weaknesses, gaps in talent, and areas in need of improvement
• Spend a minimum of 4 days/month in the field, creating relationships with treating HCPs and supporting Regional Sales Managers and Representatives
• Perform all functions in compliance with Teva’s policies and procedures

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

Education/Certification/Experience

• Bachelor’s degree required; Master’s degree preferred
• Minimum of 10 years of Biotech / Pharma experience including customer-facing responsibility (CNS, Psychiatry, Neuroscience, LAI strongly preferred)
• Minimum of 5 years Regional Sales management or similar level people management experience required (CNS, Psychiatry, Neuroscience, LAI strongly preferred). Second-line management experience strongly preferred.
• Successful track record of achieving sales goals and building, coaching, and developing effective teams required
• Previous experience in Home Office/Headquarters role or significant commercial leadership experience (e.g. Market Access) preferred

Skills/Knowledge/Abilities

• Compliantly drives performance and delivers on commitments
• Enterprise mindset focused on overall commercial success
• Collaborative and agile philosophy focused on problem solving and innovation
• Leads in an ethical, responsible, and transparent way
• Fosters communication and alignment with key stakeholders
• Operates with a sense of urgency and is accountable to people and business
• Supports a caring and high-performing culture
• Ability to drive a high-performance culture with organization focused on delivering results, generating insights, and solving complex problems
• Proven track record of driving operational excellence
• Possesses strong leadership, business acumen, and the ability to manage multiple priorities, processes, timelines, and expectations across stakeholder groups
• Demonstrated interpersonal skills, including active listening, empathy, open communication, inclusivity, and openness to feedback
• Demonstrated ability to process complex information and summarize it in writing and / or verbally; employs active listening skills
• Understanding of reimbursement coverage and pull-through strategies as well as experience in all pertinent settings of business (private practice, centers of excellence, CMHC, specialty pharmacy)
• Understanding of gross-to-net calculations and impact on PL
• Ability to focus investment in the area business where opportunities exist
• Valid US driver’s license and acceptable driving record required

TRAVEL REQUIREMENTS

• Selected candidate must live near a major airport and be able to travel regularly throughout the assigned area and attend meetings at both Teva offices and off-site locations through the US and periodically internationally as required.

PHYSICAL REQUIREMENTS

• Use a computer, including participating in face-to-face video meetings on camera.
• Sit or stand for extended periods of time.
• Travel as required, which may include travel by car, train, or plane.
• Occasionally lift up to 20 pounds.
• Occasional bending and/or twisting.

WORKING ENVIRONMENT

• May be required to wear personal protective equipment (PPE) as needed on site visits (i.e., safety glasses, hearing protection, gloves).

The annual starting salary for this position is between $198,800 – $280,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent 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.