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Medical Writing Manager

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Gilead Sciences

2mo ago

  • Job
    Full-time
    Mid Level
  • Healthcare
  • Dublin
  • Quick Apply

AI generated summary

  • You need team management skills, attention to detail, knowledge of regulatory guidelines and pediatric plans, proficiency in Microsoft Office, and relevant experience in clinical document preparation.
  • You will author clinical documents, collaborate on regulatory submissions, manage timelines, and enhance document standards while ensuring compliance with regulatory requirements.

Requirements

  • 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
  • Knowledge of pediatric plans, eg, PIPs, PSPs, PPSRs
  • Proficiency in the use of Microsoft Office and document management systems
  • Bachelor’s degree, or local equivalent, or relevant experience
  • 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.

Responsibilities

  • 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.

FAQs

What is the primary role of the Medical Writing Manager?

The primary role of the Medical Writing Manager is to prepare clinical documentation for global regulatory submissions, ensuring compliance with regulatory requirements and internal document standards while collaborating with cross-functional teams.

What types of documents will I be responsible for authoring?

You will be responsible for authoring clinical/regulatory documents such as clinical study reports, protocols and amendments, investigator brochures, as well as potentially integrated clinical summaries, pediatric investigation plans, and regulatory responses.

Will I work independently or as part of a team?

You will work as part of a team, collaborating closely with other medical writers and cross-functional teams, providing guidance and support on document strategy and presentation of data.

What qualifications are needed for this position?

A Bachelor’s degree (or local equivalent) or relevant experience in clinical research and development, regulatory affairs, or a related field is required, along with direct experience preparing clinical/regulatory documents in a medical writing or clinical submissions environment.

Are there specific knowledge areas that are important for this job?

Yes, important knowledge areas include regulatory document requirements and guidelines, as well as an understanding of pediatric plans such as PIPs, PSPs, and PPSRs.

What skills are necessary to succeed in this role?

Key skills include the ability to manage team expectations, adaptability in communication styles, attention to detail, and proficiency in Microsoft Office and document management systems.

Will I have the opportunity to participate in the development of document standards?

Yes, you will participate in the development and improvement of document standards, templates, processes, and may engage in other non-medical writing activities.

What kind of experience is considered relevant for this position?

Relevant experience includes a background in clinical research and development, regulatory affairs, or related industry/academic experience, particularly within a medical writing or clinical submissions environment.

Gilead Sciences

Science & Healthcare
Industry
10,001+
Employees
1987
Founded Year

Mission & Purpose

The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”