Document processor Jobs in San Mateo, CA

Description

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world.

Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. The Content Strategy & Development (CSD) department is part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, and advances the strategy and creation of high-quality documents to support efficient and successful regulatory submissions.

We are an inclusive and diverse community, supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance.

Job Overview/Responsibilities:

We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Manager level (Oncology). You will prepare clinical documentation for global regulatory submissions. You will have the opportunity to develop expertise in the preparation of a wide range of documents. You will work with cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Patient Safety, and Clinical Data Science) to deliver documents on time and per team expectations and drive document strategy for Medical Writing.

Key Responsibilities include:

• Author clinical/regulatory documents such as clinical study reports (all phases), protocols and amendments, and investigator brochures according to regulatory requirements and Gilead internal document standards with some input from a more senior writer.

• Work in tandem with a more senior writer on other documents types such as integrated clinical summaries, pediatric investigation plans, or regulatory responses.

• May participate in regulatory submission teams, providing guidance for optimal presentation of data to achieve document intent.

• May manage document timeline and resource planning with input from a more senior medical writer.

• Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.

Basic qualifications:

• 6+ years of relevant experience with BS/BA

• 4+ years of relevant experience with MA/MAS/ MPH/MBA

• 2+ years of relevant experience with PharmD/ PhD or equivalent

• The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams

• The ability to balance integrity and efficiency when managing attention to detail

• Knowledge of regulatory document requirements/guidelines

• Proficiency in the use of Microsoft Office and document management systems

• 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.

The salary range for this position is: $146,540.00 - $189,640.00. 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:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 for assistance.