The opportunity
As a Manager in Global Regulatory Medical Writing , you will write and edit high-quality clinical regulatory documents, including submission summaries and other complex materials critical for drug development and product registrations. You will also provide guidance, basic oversight, and resource management to ensure the seamless production of clinical research documentation that supports our mission to deliver innovative healthcare solutions.
How you’ll spend your day
- Write and edit clinical regulatory documents, including submission summaries and other complex documents.
- Ensure that documents include the proper content and context (from a regulatory medical writing perspective)and clear and consistent medical / scientific messaging, are accurate and complete, and adhere to applicableregulatory guidelines and departmental and editorial standards.
- Offer leadership and basic accountability, provide strategic assistance, and planning support for clinicalregulatory documents.
- Manage contingent workers and / or vendors.
- Provide training to others as needed.
Your experience and qualifications
PhD or PharmD in Life Sciences (or a related field), or a Master’s degree in Life Sciences (or a related field).PhD or PharmD with a minimum of 2 years of experience, or a Master’s degree with at least 4 years of experience.Preferred experience : 2-4 years in regulatory medical writing.Proficiency in Microsoft (MS) Word and advanced use of software, templates, and electronic formats for document preparation.Demonstrated expertise in writing and editing clinical regulatory documents, including submission summaries and other complex materials.Strong knowledge of government regulations related to drug development, global submission guidelines, therapeutic areas, statistical concepts, and industry standards.Proven ability to contribute to strategy development and tackle complex problems, providing actionable solutions.Skilled in facilitating effective communication to drive alignment and deliver results.Knowledge of global regulations and guidelines for document submissions.Experience in process development, improvement initiatives, and budget planning.Ability to write, edit, and oversee the creation of high-quality clinical regulatory documents.Contribute to the development of strategies under moderate supervision.Ensure timely delivery of assignments with a focus on quality.Influence and enhance communication for clear, actionable outcomes.Exceptional English proficiency, both written and spoken.Compensation
The annual starting salary for this position is between $111,000 - 146,000. 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.
Role location
US-Based Remote (US Eastern time zone preferred)
RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE
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.
Salary : $111,000 - $146,000
