דרושים Clinical Study Physician ב-טבע ב-ארהב

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 role of the Clinical Scientist is to:

• Provide scientific expertise to the clinical studies (eg: protocol, Key Results, Clinical Study Report)
• Leads, plans and executes study level activities for one or more trials with minimal supervision
• Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment)
• Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their study(ies)
• Contribute to the clinical part of regulatory documents for their projects: Common Technical Document for FDA & EMA submission, PMDA, CA, etc and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, clinical development team, and Investigators
• Be the clinical reference in the Clinical Study team related to clinical data

• Support the development of the protocol concept sheet, final protocol and protocol amendments.
• Contribute to the development, writing and review of the Clinical Development Plan (CDP).
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, site feasibility, and medical information to the study team, clinical development team, and investigators.
• Activities related to data generation and validation, including CRF (case report form) design, clinical data review/query resolution. Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts.
• Author or contribute to the development or review of medical related study documents (pre-defined protocol deviation list, the Informed Consent Form, narrative plan, study specific committee charter, etc).
• Support CRAs/CROs on study protocol and related questions and serves as a point of contact for managing/answering questions relating to trial procedures.
• Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
• Assist in the processing of responses to medical questions raised by EC/IRBs, sites.
• Review development of site and CRA training materials and presentation at site initiation visit and Investigator meetings and support on Study committee (e.g., DMC, protocol review committee).
• Support clinical aspects of Business Development and Licensing activities as needed.

• Advanced Degree required preferably in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred). Strong scientific background is required.
• A minimum of 5 years of experience in clinical development within pharmaceutical industry or CRO, specifically in clinical study design, data analysis, data review and interpretation is required.

Functional Knowledge:

• Understanding of phase I-III drug development including knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development processes.
• Demonstrates knowledge and application of statistical analysis methodology and can identify data trends and interpret data effectively through the continuum of a study.
• Knowledge of Therapeutic Area (TA) preferred, with the capability to interpret, discuss and present trial or program level data.
• Maintain knowledge of the TA, disease state and potential drug effects

Job-Specific Competencies:

• Excellent scientific communication skills, both verbal and in writing (English).
• Ability to communicate effectively with senior management and colleagues.
• Strong negotiation and conflict resolution skills.
• Strong presentation skills.
• Ability to work in a matrix organization environment.
• Highly self-motivated and proactive.
• Team player.

The annual starting salary for this position is between $227,000 – 297,000 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.

Enjoy a more rewarding choice

• 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 Clinical Research Coordinator is a primary point of contact for study participants, the Primary Investigator (PI), the Clinical Study Manager (CSM), and Department Managers in all study conduct and/or participant-related matters on the clinical research unit floor.

• Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP’s), QA/QC procedures, OSHA guidelines and other state and local regulations as applicable
• Supervises and coordinates assigned studies while working closely with CSMs and other departments to ensure all studies are conducted according to protocol
• Oversees and monitors the well-being and safety of study participants by active assessment as well as by always serving as a visible point of contact
• Facilitates verbal directions from the Principal Investigator (PI) to study participants and/or clinical study staff and ensures appropriate follow-through
• Assists the PI with the review of laboratory data results for both the selection and randomization of study participants and for the monitoring of safety parameters while study conduct is ongoing
• Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs), ensures proper documentation and reporting of all AEs, including follow up of open AEs when subjects are not in-house, and provides any appropriate clinical care or instructions to subjects, as directed by the PI or as deemed medically necessary by their professional judgment
• Continuously communicates the progress of study conduct to PI, CSM, and members of the clinical study team through various methods of communication
• Immediately notifies the PI, CSM, and members of the clinic management team upon the occurrence or reporting of a Serious Adverse Event (SAE) by a study participant and initiates documentation of the event
• Enforces rules and regulations with study participants and handles participant complaints efficiently and effectively, maintaining participant satisfaction
• Maintains compliant, clear and accurate study charts and documentation of all AEs reported and Concomitant Medication usage throughout the study
• In the absence of the Clinical Study Manager, performs as floor leader and mentor, assisting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed on the conduct floor
• Demonstrates professionalism and provides leadership to the various members of the clinical study team
• Administers study medication according to study protocol, demonstrates thorough understanding of study medications, and administers concomitant medication as directed by the PI and maintains accurate and timely documentation of the process
• Coordinates with the scheduling department to ensure coverage of clinical conduct activities
• Works with CSM and Training Manager to provide protocol training to the clinical study team, as well as to communicate on-the-spot performance direction and feedback as needed
• Oversees the completion of all End of Study or Early Termination activities by study participants, inclusive of follow-up for the close-out of any outstanding items (i.e. AEs, physical exams, lab repeats, etc.) after subjects have been discharged from the clinic
• Provides administrative and operational support to ensure successful conduct of study protocols

Education:

• A nursing degree and in-state licensure is required.
  

Experience:

• Minimum of two (2) years of experience in a clinical research environment
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific experience listed above.
• Certification/Licensure Advanced Cardiovascular Life Support (ACLS) certification and Nurse Licensure in the State of Florida are required.
• Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)
• Possesses leadership skills and abilities
• Able to provide excellent customer service, with experience in public relations
• Able to communicate professionally and effectively both verbally and in writing with participants from diverse backgrounds
• Able to work independently and handle multiple competing priorities
• Able to multi-task working within tight deadlines
• Able to function independently within a team environment
• Possesses excellent organizational and time-management skills and a strong attention to detail

Physical Requirements and Working Conditions:

• Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 50 pounds.

Physical Demands:

• Variable shifts including nights and weekends

Work Environment:

• Predominantly clinical conduct environment
• Non-supervisory team leadership

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 annual starting salary for this position is between $61,680 – $80,955 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.

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.

A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other departments as appropriate) in the production of submission-ready clinical research documentation in support of drug development, product registrations, and product marketing. The Clinical Publisher's primary responsibility focuses on document publishing activities, but includes assignment to initiatives and or other tasks and projects as directed.

The Clinical Publisher is responsible for formatting documents and ensures that GRMW documentation developed by Medical Writers adheres to applicable regulatory guidelines and departmental standards.

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.

• Publishes clinical documents (protocols, IBs, DSURs, CSRs, summary documents, and others)
• Manages preparation of stand-alone documents and Clinical Study Reports (CSRs)
• Document formatting requiring competence in Microsoft (MS) Word and Adobe Acrobat Professional and Plug-Ins
• Manages all documents level projects, smaller scale publishing projects and submissions with assistance
• Provides business support for Medical Writing systems such as Veeva, PleaseReview, SharePoint and others
• Provides template, style guide, PleaseReview and other supportive training and expertise to medical writers
• Has a good understanding of processes and systems involved with publishing of GRMW clinical documents
• Performs administrative or other responsibilities
• Participates in meetings for submissions and others as requested
• Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents

Required:

• Bachelor’s degree in life sciences (or other related field)
• Excellent English, both written and spoken
• Strong attention to detail, clarity and accuracy
• Significant editing skills and proficiency in the use of relevant software applications, and using templates and other electronic formats
• Advanced Word processing skills (e.g., use of custom MS Word templates and macros)
• Advanced knowledge of Adobe Acrobat Professional and Plug-Ins

Technical skills

• Significant knowledge of government regulations pertaining to drug development and understanding of the Company’s products and Standard Operating Procedures (SOPs)
• Ability to organize and present information, and to communicate GRMW processes and technical and editorial standards
• Excellent organizational/planning and problem-solving skills at the product and program level

Preferred:

• 2 Years of experience related to clinical document publishing or regulatory submission publishing
• 2 Years of experience in the pharmaceutical industry with depth of knowledge related to the conduct of clinical trials and global submissions
• Experience with Veeva as EDMS
• Knowledge of ICH/FDA/EU guidelines (clinical documents and publishing) and regulations

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.

In this role you will:• Achieve all sales performance goals and objectives for geographical assignment
• Demonstrate a collaborative sales approach and coordinate efforts between sales leadership, other Teva sales teams, market access, sales operations, and training.
• Develop effective business plans to meet and exceed territory-level sales goals. Possess the understanding and ability to sell in different settings of care and identify key business opportunities within these settings.
• Build rapport and relationships by interacting effectively with employees and external contacts (i.e., HCP and 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, as well as medical office staff to appropriately promote product and provide product and patient education
• Maintain a call average as outlined in the sales plan, defined as face-to-face interactions, with healthcare providers focusing on top target customers
• Apply a range of traditional and non-traditional problem-solving techniques to think through and solve issues creatively to improve performance and company effectiveness
• Adhere to all Teva’s compliance policies and guidelinesCurrent territory boundaries include:

• Northwest – Burlington, Vermont
• Central – Lebanon, New Hampshire
• South – Nashua and Manchester, NH
• West – Keene, NH

It’s a pretty large geography and essentially covers ALL of NH with only a couple of exceptions (Portsmouth, NH) and most of Vermont

• Bachelor's degree required
• Full time documented business to business sales experience preferred
• Pharmaceutical sales experience preferred, experience in psychiatric therapeutic areas strongly preferred
• Record of successfully achieving sales goals and building effective customer relationships
• Experience successfully launching products in the psychiatric space across multiple settings of care
• Ability to interact with customers in live and virtual environments and proficiency with technology
• Understanding of reimbursement coverage and pull through strategies as well as experience in all pertinent settings of business (CMHC, specialty pharmacy, private practice)
• Demonstrated leadership and interpersonal skills
• Knowledge of reimbursement, managed care, or marketing preferred Proven written and verbal communication skills
• Experience calling on community mental health centers (CMHC) is a plus
• Ability to travel as required, which may include overnight and/or weekend travel
• Valid US driver's license and acceptable driving record required
• Candidate must be able to successfully pass background, motor and drug screening
• Occasional lifting of up to 20 pounds

• Sales Specialist: Less than 3 years
• Professional level: 3 years
• Senior level: 5 years
• Executive: 7 years

The annual starting salary for this position is between $75,000 – 155,000 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.

Travel Requirements:
• Ability to travel with overnight stays, as required

Essential Duties & Responsibilities:

• Sr.Dir CP is responsible for the CP/early clinical development deliverables for their programs teams:
  
  • Support the clinical pharmacology strategy across their specific programs
  • Generation of CP information and integration with up-to-date regulatory and scientific resources to inform decision-making and bring value to the programs.
  • Planning, direction, and interpretation of clinical pharmacology studies defined in the Clinical Development Plan
  • Participates in planning, writing and leading clinical pharmacology related modules of regulatory documents and application
• Supports company clinical development strategy by:
  • Assessing impact of new and evolving relevant operational, scientific, and regulatory strategies and industry trends
  • Keeping abreast with relevant regulations and scientific literature.
  • Promotes the value of ClinPharm by sharing professional knowledge with external stakeholders
  • Developing consistent CP processes.
• Responsible for financial planning/forecasting and budget management of their program.
• Represents CP with internal and external stakeholders, and at relevant governances.
• Initiates, develops, leads and participates in company initiatives to meet cross functional drug development objectives and other continuous improvement to achieve innovation in drug development, cost –reduction, time-savings, efficiency and quality business objectives.
• Represents clinical pharmacology and defend clinical pharmacology strategy and study results and interpretation at regulatory interactions.
• Follows Teva Safety, Health, and Environmental policies and procedures

Requirements:

• PhD in Clinical pharmacology, pharmacology, pharmaceutical sciences, life sciences/chemistry/biology or related fields and relevant experience of a minimum of 12 years in the pharmaceutical industry (preferred), academia or regulatory agency such as the FDA. A post pectoral fellowship can be counted towards relevant experience.
• MD and a minimum 12 years of relevant experience in the pharmaceutical industry (preferred) or post completion of degree in research or medical practice or with regulatory authorities such as the FDA.

Preferred:

• Experience/training in population PK/PD analyses.
• Experience in more than one therapeutic area and in early development
• Proven track record of delivering results, including filing of INDs and NDAs.
• Experience with software used for NCA and pharmacometric modeling preferred.

Functional Knowledge:

⦁ Excellent understanding of drug development process.
⦁ Proven leadership in the transition of discovery programs into clinical development and submissions.
⦁ In-depth knowledge and expertise in developing small and large molecule therapeutics.

Company/Industry Related Knowledge:

• Experience in change management
• Global/international experience, including ability to lead intercultural regionally based programs teams

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 holiday.
• 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.

The Director, Clinical Development will provide input to the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, early clinical and pre-clinical development in this regard. The Director will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings.

The Director, Clinical Development will foster relationships with opinion leaders in assigned Respiratory/pulmonary/atopic disease areas.

• Will be a core member of the Global Project Team
• Will have and maintain the expertise necessary for the clinical development of the product
• Prepares and manages multiple Clinical Development Plans
• Leads or oversees the cross-functional clinical development team
• Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion
• Makes presentations at the Investigator Meetings and other relevant internal or external venues
• Responsible for securing the required human resources to implement the Clinical Development plan
• Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement with the clinical supplies group
• Ensures clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures
• Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and the Disease Area Heads, as needed.
• Oversees the preparation of documents for IND/NDA and other regulatory documents
• May lead an NDA submission team independently, as needed
• Partners cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global Clinical Operations, and CROs in the execution of Clinical Development Plans (CDPs)
• Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing
• Working with Medical Writing team, responsible for authoring protocol synopses, providing input and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant clinical documents
• Author and/or review abstracts, posters and manuscripts, present data at scientific meetings, as needed
• Represent Teva at Scientific meetings, advisory boards, KOL boards and meetings with regulatory agencies, as needed

Your experience and qualifications:

• MD, DO or equivalent combination of education and related work experience. PhD, PharmD, DVM with strong proven track record will be considered
• Minimum of 2 years’ experience in a pharmaceutical industry environment or related area planning/managing clinical trials, with proven ability to manage projects and/or lead project teams effectively. MD/DO without prior industry experience but with relevant knowledge and expertise, in clinical trials will be considered
• Experience in the Respiratory/pulmonary/allergy therapeutic area is strongly preferred
• Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks preferred
• Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast-paced, multi-tasking environment

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, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but 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.