What are the responsibilities and job description for the QC Specialist position at Teva Pharmaceuticals?
Who We Are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The QC Specialist provides clinical and scientific quality checks for all clinical study and submission documents for assigned projects. The role is responsible for support of medical writing activities involved in US, European, and other regulatory submissions. The QC Specialist will be accountable for ensuring that deliverables are in line with Teva’s Authoring and QC standards/checklists. The role also includes overseeing vendor management, including contingent workers, where applicable.
Travel Requirements: None
How You’ll Spend Your Day
Provides independent data QC review of clinical regulatory documents including, but not limited to, clinical summary documents, clinical study reports, investigator’s brochures, clinical protocols, briefing books, prior to submission to Health Authorities.
Works cross functionally to continuously improve processes.
Requirements
Your experience and qualifications
Proficient in Microsoft Office, Document management systems, hyperlinking and bookmarking
Functional Knowledge
We Offer a Competitive Benefits Package, Including
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
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.
Teva’s Equal Employment Opportunity Commitment
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The QC Specialist provides clinical and scientific quality checks for all clinical study and submission documents for assigned projects. The role is responsible for support of medical writing activities involved in US, European, and other regulatory submissions. The QC Specialist will be accountable for ensuring that deliverables are in line with Teva’s Authoring and QC standards/checklists. The role also includes overseeing vendor management, including contingent workers, where applicable.
Travel Requirements: None
How You’ll Spend Your Day
Provides independent data QC review of clinical regulatory documents including, but not limited to, clinical summary documents, clinical study reports, investigator’s brochures, clinical protocols, briefing books, prior to submission to Health Authorities.
- Performs accurate and precise editing or proofreading ensuring correct spelling, grammar, punctuation and data verification.
- Identifies discrepancies and assesses accuracy and validity of clinical statements in documents.
- Verifies content to ensure accuracy (100% review) of all factual statements within document text compared to post-text sources cited (when appropriate).
- Verifies numeric accuracy (100% review) of all data cited throughout text compared to in-text or post-text tables.
- Verifies all internal and external citations noted within summary document.
- Ensures compliance of document format per the template and style guide.
- Develops and provides factual evidence to support all discrepant findings for review and approval by document authors and subject matter experts of the cross-functional team.
- Assesses outsourcing needs and resources
- Estimates/revises budgets
- Serves as primary contact for file sharing, queries, and issue escalation, as needed
Works cross functionally to continuously improve processes.
Requirements
Your experience and qualifications
- PhD, PharmD, Masters degree, or Bachelors degree in English/Life Sciences
- Minimum 3 years of QC experience
- Minimum 5 years in the pharmaceutical or medical industry
Proficient in Microsoft Office, Document management systems, hyperlinking and bookmarking
Functional Knowledge
- The ability to fluently read, write, understand and communicate in English
- Experience in clinical research with proven proficiency in global clinical development
- Ability to understand and interpret complex clinical and/or scientific and statistical data and effectively communicate inaccuracies in technical documents to authors.
- Demonstrate strong medical and/or scientific communications (written)
- Proven ability to work independently to deliver clinical technical document discrepant findings within defined timelines.
- Previous experience in clinical development of clinical technical document deliverables with knowledge in world-wide regulatory requirements for drug and device registration
- Ability to conduct thorough and accurate research, have logical organizational skills, clear readable writing, and adherence to required templates.
- Solid computer technical skills (Word/Excel/PDF development), ability to acquire skills in accordance with company and external writing standards, and learn new systems quickly.
- Strong knowledge of global regulatory requirements
- An understanding of the clinical drug development process, including clinical trial design, operations, and results analysis
- Knowledge of global regulations/guidelines for document submissions and authoring styles (eg, AMA)
- Excellent English, both written and spoken
- Excellent interpersonal skills, written and verbal communication skills, and administrative skills
- Leads process development and improvement
- Tackles difficult problems; Identifies solutions and recommends action to management
- Manages and delivers assignments with quality and within timelines
- Provides input for budget planning
- Attention to detail is a must
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.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
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.
Teva’s Equal Employment Opportunity Commitment
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
