Intern - Regulatory Affairs - Medical Writing

Location
Foster City, CA, United States
Posted
Dec 16, 2020
Ref
2101800
Required Education
Bachelors Degree
Position Type
Full time
Intern - Regulatory Affairs - Medical Writing
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. 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’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Prepares regulatory documents such as Phase 1 or 2 CSRs and IBs in line with regulatory requirements and Gilead internal document standards. Works under the direction of a more senior writer.
? Contributes to other nonregulatory medical writing activities as required.
? Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring all source information/data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines.
? Ensures final compilation of document components, coordinating with functional area representatives (eg, Clinical Research, Biometrics, and Regulatory Affairs) to ensure that contributions are complete.
? Develops expertise in the preparation of regulatory documents particularly at the individual study report level.
? Has excellent verbal communication skills and attention to detail. Shows flexibility in communication style to work effectively with a variety of team preferences.
? Has well developed computer skills including proficiency in Word, Adobe, and Excel; works proficiently within the RDMS system.
? Attends and participates in routine departmental meetings.

Key Differentiating Contributions:
? Has basic knowledge of the medical writer's role on teams and in document authoring processes. Has demonstrated some degree of technical writing proficiency; may review data produced for assigned documents with guidance from a more senior writer.
? With close supervision by a more senior writer, authors documents of limited complexity, such as Phase 1 or 2 clinical study reports (CSRs), investigator brochure (IBs) updates, or other documents as appropriate for the level of experience.
? Performs other tasks pertinent to regulatory document production such as quality control (QC) reviews, compilation of document appendices, creation or formatting of tables to optimally present data, process improvement work, and medical editing reviews.
? Has close attention to detail, ability to function well within a cross-functional team environment.

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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 ‘EEO is the Law' poster.

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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:

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