Senior Manager, Medical Writing
Full Time
Seattle, WA 98102
$146,200 - $189,200 a year
Posted
Job description
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Job Description
We have an exciting and unique opportunity for a Medical Writer (Oncology) to join our dynamic team at the Senior Manager level. You will prepare clinical documentation to support global regulatory submissions. You will have the opportunity to develop expertise in the preparation of a wide range of documents, particularly at the individual study report and submission level. You will work collaboratively within cross-functional teams (eg, Regulatory, Clinical Research, Pharmacovigilance, and Biometrics) to deliver documents on time and per team expectations.
Key Responsibilities:
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Independently author clinical/regulatory documents such as protocols and amendments, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards.
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Author high complexity documents such as integrated CTD summaries/overviews, PIPs/PIP modifications, or regulatory responses with some input from a more senior writer.
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May serve as a filing lead for a small to medium regulatory submission, with responsibilities including development and management of document timelines and resource planning for assigned projects.
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May serve as lead medical writer and department representative on a medium to large development program.
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Participates in multiple cross functional teams (eg, regulatory submission teams or regulatory project teams) providing advice/guidance to the team on regulatory document requirements or on optimal presentation of data for achievement of document objectives.
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May coach, train, and provide guidance to less experienced writers.
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May manage or supervise direct reports and contract medical writers to ensure the highest quality of medical writing and adherence to Gilead document standards.
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Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.
You Will Need:
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The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams
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The ability to balance integrity and efficiency when managing attention to detail
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Knowledge of regulatory document requirements/guidelines
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Proficiency in the use of Microsoft Office and document management systems
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Bachelor’s degree or higher, or local equivalent, or relevant experience
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Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment
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Knowledgeable of regulatory document requirements/guidelines
The salary range for this position is: $146,200.00 - $189,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact
careers@gilead.com
for assistance.
For more information about equal employment opportunity protections, please view the
'Know Your Rights'
poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
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