Large

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?”

Science & Healthcare

Gilead Sciences

Science

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.

Healthcare

Dublin

<p><span style="background-color: transparent;">The Role:</span></p><p><span style="background-color: transparent;">We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Manager level. 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.</span></p><p><span style="background-color: transparent;">Key Responsibilities:</span></p><ul><li>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.</li><li>Work in tandem with a more senior writer on other documents types such as integrated clinical summaries, pediatric investigation plans, or regulatory responses.</li><li>May participate in regulatory submission teams, providing guidance for optimal presentation of data to achieve document intent.</li><li>May manage document timeline and resource planning with input from a more senior medical writer.</li><li>Participates in <span style="background-color: transparent;">development/improvement</span> of document standards, templates, and processes and other non-medical writing activities.</li></ul><p><span style="background-color: transparent;">You Will Need:</span></p><ul><li>The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams</li><li>The ability to balance integrity and efficiency when managing attention to detail</li><li>Knowledge of regulatory document requirements/guidelines</li><li>Knowledge of pediatric plans, eg, PIPs, PSPs, PPSRs</li><li>Proficiency in the use of Microsoft Office and document management systems</li><li>Bachelor’s degree, or local equivalent, or relevant experience</li><li>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.</li></ul>

The Role:We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Manager level. 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: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.You Will Need:The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teamsThe ability to balance integrity and efficiency when managing attention to detailKnowledge of regulatory document requirements/guidelinesKnowledge of pediatric plans, eg, PIPs, PSPs, PPSRsProficiency in the use of Microsoft Office and document management systemsBachelor’s degree, or local equivalent, or relevant experienceRelevant 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.

Medical Writing Manager - Gilead Sciences

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  For Current Gilead Employees and Contractors:
 </div>
 <div>
   Please log onto your 
  <div>
   Internal Career Site
  </div> to apply for this job.
 </div>
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   At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
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  <br> Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
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  <br> We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
  <br> 
  <br> Job Description
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  <br> 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.
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   Gilead has established employee resource groups to support 
  <div>
   diversity and inclusion
  </div>, and provides a competitive benefit package including flexible work options and exceptional support for the family and the individual.
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  <div>
   <i> www.gilead.com</i>
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   Medical Writing is a global, dynamic, and diverse team of highly skilled professionals. We work collaboratively to advance the strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking into our daily work. Medical Writing resides within Regulatory Affairs. We are dedicated to attracting new talent with diverse backgrounds and experiences and committed to providing individual development and growth opportunities while promoting a healthy work-life balance.
 </div>
 <div></div>
 <div>
   The Role:
 </div>
 <div></div>
 <div>
   We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Manager level. 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.
 </div>
 <div></div>
 <div>
   Key Responsibilities:
 </div>
 <div></div>
 <ul>
  <li> 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.</li>
  <li> Work in tandem with a more senior writer on other documents types such as integrated clinical summaries, pediatric investigation plans, or regulatory responses.</li>
  <li> May participate in regulatory submission teams, providing guidance for optimal presentation of data to achieve document intent.</li>
  <li> May manage document timeline and resource planning with input from a more senior medical writer.</li>
  <li> Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.</li>
 </ul>
 <div></div>
 <div>
   You Will Need:
 </div>
 <div></div>
 <ul>
  <li> The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams</li>
  <li> The ability to balance integrity and efficiency when managing attention to detail</li>
  <li> Knowledge of regulatory document requirements/guidelines</li>
  <li> Knowledge of pediatric plans, eg, PIPs, PSPs, PPSRs</li>
  <li> Proficiency in the use of Microsoft Office and document management systems</li>
  <li> Bachelor’s degree, or local equivalent, or relevant experience</li>
  <li> 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.</li>
 </ul>
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  <br> Equal Employment Opportunity (EEO)
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   It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 </div>
 <div></div>
 <div>
  <br> For Current Gilead Employees and Contractors:
 </div>
 <div>
   Please log onto your 
  <div>
   Internal Career Site
  </div> to apply for this job.
 </div>
</div>

Gilead Sciences

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