Tevapharm
Director, Therapy Area Head, Global Regulatory Medical Writing (USA, Remote)
Tevapharm, Parsippany, New Jersey, us, 07054
Director, Therapy Area Head, Global Regulatory Medical Writing (USA, Remote)
Date: Oct 19, 2024 Location: Parsippany, United States, New Jersey, 07005 Job Id: 57648 Who we are
Teva is a global pharmaceutical leader. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. At Teva, we strive to deliver quality medicines to patients around the world with integrity and ethical business practices. Our culture is about not only what we do, but how we do it. We innovate to create value for patients, our partners in the healthcare system and our stakeholders. We constantly look for original and better ways to excel, creating solutions for current and future unmet needs. The opportunity
As a
Director, in Global Regulatory Medical Writing (GRMW) , you will primarily work in a therapeutic area specific role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a significant level of oversight and SME guidance to internal medical writing team and cross-functional matrixed project teams in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug development and product registrations. In this role you will offer clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various regulatory and reporting purposes in an E2E business model. As per business needs, you may write and edit clinical regulatory documents, including submission summaries and other complex documents. How you’ll spend your day
Manage a team of direct reports; oversee contingent workers and/or vendors; provide training to others; strategically analyze needs to manage resources and take accountability for resource allocation for therapeutic specific business needs with support from the department head. Oversee/provide guidance and accountable for all document types prepared by medical writers, review documents internally within medical writing function before stakeholder engagement, may write and edit clinical regulatory documents (all types) as per business needs. Ensure that documents are fit-for-purpose, contain clear and consistent medical/scientific messaging that are accurate and complete, adhere to applicable regulatory guidelines, ICH guidance, and Teva standards. Lead/contribute to the preparation/revision of document templates. Participate in the recruiting/hiring process, development of direct reports including identifying learning/training opportunities, performance assessment and reviews. Responsible for tracking/providing team metrics and establish key performance indicators. Your experience and qualifications
PhD or PharmD in life sciences (or other related field) with a minimum of 8 years of experience; Master’s degree in life sciences (or other related field) with minimum of 10 years of experience. Expert in all document types. Oversees/mentors for all document types at therapeutic area or functional level. Guides/oversees medical writers; considered a proficient manager with regulatory medical writing expertise. Considered an internal expert in all aspects of regulatory medical writing and clinical drug development. Influences and potentially leads creation of regulatory medical writing processes and standards. Serves as subject matter expert for the Medical Writing function. Knowledge of global regulations and guidelines for document submissions, and experienced in leading regulatory global submissions. Excellent written and oral communication skills. Team player, dynamic, engaged, and agile to drive business needs and execute departmental vision at Teva. Primary accountability is delivering high quality documents that are fit-for-use and within timelines with medical writing colleagues. Represents MW in program teams providing leadership and guidance as an SME. Addresses business/program/project level issues; makes independent decisions using past experience and current situation to drive solutions and mitigate risks. Persuades and inspires team to take action; coaches and mentors junior medical writers and team as applicable to build MW SME presence, has expert negotiation skills. Contributes to content preparation for departmental initiatives, participates in process development, and improvement cross-functionally with direction from department head. Leads development of process, and preparation/revision of SOPs and guidance documents with department head and medical writing LT team. Forecasts and maintains budget as per business needs and direction from department head. This is a remote opportunity and can be based anywhere in the United States. 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, 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. Reports To
Head of Global Regulatory Medical Writing Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
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Date: Oct 19, 2024 Location: Parsippany, United States, New Jersey, 07005 Job Id: 57648 Who we are
Teva is a global pharmaceutical leader. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. At Teva, we strive to deliver quality medicines to patients around the world with integrity and ethical business practices. Our culture is about not only what we do, but how we do it. We innovate to create value for patients, our partners in the healthcare system and our stakeholders. We constantly look for original and better ways to excel, creating solutions for current and future unmet needs. The opportunity
As a
Director, in Global Regulatory Medical Writing (GRMW) , you will primarily work in a therapeutic area specific role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a significant level of oversight and SME guidance to internal medical writing team and cross-functional matrixed project teams in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug development and product registrations. In this role you will offer clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various regulatory and reporting purposes in an E2E business model. As per business needs, you may write and edit clinical regulatory documents, including submission summaries and other complex documents. How you’ll spend your day
Manage a team of direct reports; oversee contingent workers and/or vendors; provide training to others; strategically analyze needs to manage resources and take accountability for resource allocation for therapeutic specific business needs with support from the department head. Oversee/provide guidance and accountable for all document types prepared by medical writers, review documents internally within medical writing function before stakeholder engagement, may write and edit clinical regulatory documents (all types) as per business needs. Ensure that documents are fit-for-purpose, contain clear and consistent medical/scientific messaging that are accurate and complete, adhere to applicable regulatory guidelines, ICH guidance, and Teva standards. Lead/contribute to the preparation/revision of document templates. Participate in the recruiting/hiring process, development of direct reports including identifying learning/training opportunities, performance assessment and reviews. Responsible for tracking/providing team metrics and establish key performance indicators. Your experience and qualifications
PhD or PharmD in life sciences (or other related field) with a minimum of 8 years of experience; Master’s degree in life sciences (or other related field) with minimum of 10 years of experience. Expert in all document types. Oversees/mentors for all document types at therapeutic area or functional level. Guides/oversees medical writers; considered a proficient manager with regulatory medical writing expertise. Considered an internal expert in all aspects of regulatory medical writing and clinical drug development. Influences and potentially leads creation of regulatory medical writing processes and standards. Serves as subject matter expert for the Medical Writing function. Knowledge of global regulations and guidelines for document submissions, and experienced in leading regulatory global submissions. Excellent written and oral communication skills. Team player, dynamic, engaged, and agile to drive business needs and execute departmental vision at Teva. Primary accountability is delivering high quality documents that are fit-for-use and within timelines with medical writing colleagues. Represents MW in program teams providing leadership and guidance as an SME. Addresses business/program/project level issues; makes independent decisions using past experience and current situation to drive solutions and mitigate risks. Persuades and inspires team to take action; coaches and mentors junior medical writers and team as applicable to build MW SME presence, has expert negotiation skills. Contributes to content preparation for departmental initiatives, participates in process development, and improvement cross-functionally with direction from department head. Leads development of process, and preparation/revision of SOPs and guidance documents with department head and medical writing LT team. Forecasts and maintains budget as per business needs and direction from department head. This is a remote opportunity and can be based anywhere in the United States. 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, 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. Reports To
Head of Global Regulatory Medical Writing Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
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