דרושים ב-Teva ב-Switzerland

The role of the RIM team is to:

• Develop and implement the RA business systems strategy required to ensure that Global Regulatory Affairs (GRA) systems continue to meet ongoing and emerging business needs.
• Provide the expert business analysis input required for the successful development of strategic system roadmaps and for the successful implementation of the projects required to ensure the delivery of the technology solutions required to support the GRA business and its partner functions.
• Provide RA Business Data Administration and Business System Ownership, including system and data related business change management, in support of the RA business process and data requirements, and compliant system usage.
• Partner with external pharmaceutical industry stakeholders (e.g. industry associations) and health authorities to influence outcomes relating to emerging requirements such as ISO IDMP and FMD etc.
• Manage and deliver the Teva XEVMPD submissions related to Investigational Medicinal Products, review and remediate Authorized Medicinal Products 3rd acknowledgment and EMA follow up reports to ensure Article 57 compliance.
• Support PV in case of audits and inspections, provide Teva XEVMPD records EV web reports, review and/or remediate the Teva xevmpd records (if required) including collaboration on CAPA plan in case any finding is related to RIM/xevmpd data
• Support the in-house Regulatory Data Administration team for the management of Teva registration data. This includes support for data integration and data integrity/enrichment initiatives to ensure compliant and reliable RA data for accurate reporting and business decisions making.

TheRIM Business Analyst/Project Managerwill support and enable the successful execution of this role.

• Responsible for supporting effective business project management for regional and global projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data and documents or the regulatory technology landscape.
• Required to lead cross-regional and cross-functional projects teams, working and influencing staff at all levels within the organization to ensure regulatory systems, and related processes, are developed and enhanced to meet the diverse regulatory business process and data requirements.

The
RIM Business Analyst/Project Managerwill work closely with the Harlow based RIM and GRO Regulatory Data Administration teams. Will work closely with the GRA functional teams dependent upon these operations. Will act as change manager, and/or escalation point for these operations to ensure their continued effectiveness, and to ensure GRA business needs continue to be met by these operations.

• They will be an effective Business Analyst, responsible for deep dives in to current and mapping future business process, be expert in interrogating regulatory legislative and guidance documents and draw on that expertise to shape the to-be processes to ensure business compliance.
• Responsible for providing effective Business Data Administration oversight for GRA data (e.g. for the data management/data quality decisions that impact system dictionary-controlled values and for defining, obtaining agreement to, and communicating, GRA data process related work instructions etc.)
• Must be fluent with Pharmaceutical Regulatory Affairs business processes.
• Must leverage deep regulatory business expertise to successfully partner with Regulatory Affairs functional/strategy teams, and IT etc.
• Must understand evolving regulatory requirements and guidelines.
• Must be able to understand and define new RA business requirements, translate those into strategic project proposals for change and to deliver those projects.
• Must be analytical, methodical, and able to successfully analyse data, process, and external regulatory requirements.
• Must be a highly effective communicator, capable of relaying complex concepts to all levels and functions of the company.

Qualfication:

• Required: Bachelor’s Degree in Life Sciences or Information Technology
• Preferred: MS in scientific or information technology discipline

Required:

• 3 to 5 demonstrable experiences of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Demonstrable experience of leading cross-functional project teams and change projects, including working within a multifunctional/geographical matrix.
• Demonstrable experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing RA business data demands.

Preferred:

• Extensive experience of the pharmaceutical industry with direct experience in Regulatory Affairs.
• Extensive experience of leading cross functional project teams and change projects, including working within a multifunctional and geographical matrix.
• Extensive experience of analysing the data requirements of RA business processes and of managing regulatory data in line with the high standards required to maintain regulatory compliance and to support the growing business process data demands.
• Experience with Parexel/Liquent’s Insight/Veeva regulatory information management suite of products.

• Knowledge of global (FDA, EMA, Health Canada and Japan) regulatory requirements.
• Knowledge of global industry initiatives and direction.
• Knowledge of industry regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP, SPOR, RIM systems etc).
• Understanding of regulatory business processes: regulatory submission, CMC, product strategy, registration/regulatory data management..
• Understanding of the drug development process for generics, branded, and Non-Med product development a plus.
• Working knowledge of system and business process design and implementation a plus.

Sr Manager, RIM, Global Regulatory Operations

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.

• Build rapport and relationships by interacting effectively with regional team members and key external contacts (ie, HCP and entire office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action
• Provide healthcare product demonstrations, physician detailing, and in-servicing of products to current and potential customers
• Consult with physicians, nurses, and medical office staff to appropriately promote product and provide product and patient education
• Strategically manage and grow relationships with key accounts by tailoring solutions to meet their unique needs, leveraging industry insights to drive product differentiation and achieve sales targets
• Regularly review and analyze all provided sales data in order to create effective territory plans and utilize promotional budget funds
• 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
• Open to working with cross-functional teams to integrate diverse expertise and insights and achieve shared objectives
• Maintain a call average as outlined in the sales plan, defined as face-to-face interactions, with healthcare providers focusing on top target customers
• Take calculated risks and apply a range of traditional and nontraditional problem-solving techniques to solve issues creatively in order to improve performance in geographical assignment
• Adhere to all Teva’s compliance policies and guidelines
• Achieve all sales performance goals, reach objectives, and complete all administrative duties for geographical assignment

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, preferably in related field
• At least 1 year of full-time, documented business-to-business sales experience; pharmaceutical sales experience strongly preferred

Skills/Knowledge/Abilities

• Proven record of accomplishments in this specific market toward meeting established objectives
• Demonstrated interpersonal skills, including active listening, empathy, open communication, inclusivity, and openness to feedback
• Well-developed written and oral communication skills
• Ability to interact with HCPs in both face-to-face and virtual environments, and be proficient with technology
• Knowledge of reimbursement, managed care, or marketing preferred
• New product launch experience preferred
• Broad therapeutic area experience particularly in therapeutic area preferred
• Candidate must be able to successfully pass background, motor, and drug screening
• Valid US driver’s license and acceptable driving record required

Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.

• Sales Specialist : Minimum 1 year
• Executive Sales Specialist : Minimum 7 years

TRAVEL REQUIREMENTS

Regular travel, which may include air travel and weekend or overnight travel

The annual starting salary for this position is between $88,000 – $170,000 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.

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