Senior Manager Medical Writing - Innovative Medicine R&d East jobs at Teva in United States, Macon
Teva Senior Manager Medical Writing - Innovative Medicine R&D Eas... United States, Georgia, Macon
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As a, you will write and edit clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registrations. You will provide intermediate-level oversight, guidance, and resource management to ensure the effective production of high-quality clinical research documentation.
How you’ll spend your day
- Focus on product and program-level responsibilities, providing leadership and accountability for key regulatory documents.
- Potentially oversee direct reports, contingent workers, and/or vendors, while also offering training and resource management support.
- Provide strategic supervision, leadership, and planning for the development of clinical regulatory documents.
- Write and edit various types of clinical regulatory documents, ensuring content is accurate, complete, and adheres to regulatory guidelines and editorial standards.
- Ensure documents are clear, consistent, and align with regulatory medical writing best practices, including appropriate context and scientific messaging.
- Contribute to the preparation and revision of document templates, enhancing process efficiency and quality.
- PhD or PharmD in Life Sciences (or related field) with a minimum of 4 years of experience, or a Master’s degree in Life Sciences (or related field) with at least 6 years of experience.
- Preferred experience: 4-6 years in regulatory medical writing.
- Proficient in Microsoft (MS) Word and adept at using software, templates, and electronic formats for document preparation.
- Recognized as a competent manager with advanced expertise in regulatory medical writing.
- Skilled in writing and editing various types of clinical regulatory documents, ensuring clarity, accuracy, and compliance with regulatory guidelines.
- Advanced understanding of global regulations and guidelines for document submissions, therapeutic areas, statistical concepts, and product development.
- Strong English language proficiency, both written and spoken.
The annual starting salary for this position is between $121,000 - 159,000. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
This position may also be eligible for bonus. Level of the role will be commensurate to years of experience and performance criteria.
US-Based Remote (US Eastern time zone preferred)
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.
These jobs might be a good fit
Share
As a, you will write and edit clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registrations. You will provide intermediate-level oversight, guidance, and resource management to ensure the effective production of high-quality clinical research documentation.
How you’ll spend your day
- Focus on product and program-level responsibilities, providing leadership and accountability for key regulatory documents.
- Potentially oversee direct reports, contingent workers, and/or vendors, while also offering training and resource management support.
- Provide strategic supervision, leadership, and planning for the development of clinical regulatory documents.
- Write and edit various types of clinical regulatory documents, ensuring content is accurate, complete, and adheres to regulatory guidelines and editorial standards.
- Ensure documents are clear, consistent, and align with regulatory medical writing best practices, including appropriate context and scientific messaging.
- Contribute to the preparation and revision of document templates, enhancing process efficiency and quality.
- PhD or PharmD in Life Sciences (or related field) with a minimum of 4 years of experience, or a Master’s degree in Life Sciences (or related field) with at least 6 years of experience.
- Preferred experience: 4-6 years in regulatory medical writing.
- Proficient in Microsoft (MS) Word and adept at using software, templates, and electronic formats for document preparation.
- Recognized as a competent manager with advanced expertise in regulatory medical writing.
- Skilled in writing and editing various types of clinical regulatory documents, ensuring clarity, accuracy, and compliance with regulatory guidelines.
- Advanced understanding of global regulations and guidelines for document submissions, therapeutic areas, statistical concepts, and product development.
- Strong English language proficiency, both written and spoken.
The annual starting salary for this position is between $121,000 - 159,000. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
This position may also be eligible for bonus. Level of the role will be commensurate to years of experience and performance criteria.
US-Based Remote (US Eastern time zone preferred)
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.
These jobs might be a good fit
