Associate Director Medical Writing
Associate Director Medical Writing
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
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Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Associate Director Medical Writing
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
For Current Gilead Employees And Contractors:
Please log onto your Internal Career Site to apply for this job.
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 COVID19 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.
Every member of Gilead’s team plays a critical role in the discovery and development of lifechanging 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.
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.
Job Description
Medical Writing acts as a strategic partner across drug discovery development and commercial teams. Medical Writing participates in crossfunctional drug discovery development and commercial product lifecycle management and contributes strategic expert input into scientific and regulatory content that is used for a variety of purposes including critical regulatory submissions. Medical Writing collaborates crossfunctionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world.
We have an exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents independently including novel or atypical documents which require ingenuity and considerable medical writing expertise and autonomy. You will define the Medical Writing strategy plans and objectives for assigned products or projects. You will represent Medical Writing on relevant product project and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other crossfunctional initiatives. You may serve as the filing lead for large complex regulatory submissions and as lead medical writer for a large development program or TA. You will participate in or may lead Medical Writing and crossfunctional process improvement initiatives on regulatory document standards template development and document process. You may manage or supervise direct reports and contractors overseeing recruitment and onboarding.
EXAMPLE RESPONSIBILITIES:
We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry. Experience leading a broad range of medical writing or related deliverables and setting the medical writing or related strategy for biopharmaceutical products.
Knowledge & Other Requirements
For Additional Benefits Information Visit:
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 nonjob 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.
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.
Please log onto your Internal Career Site to apply for this job.
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 COVID19 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.
Every member of Gilead’s team plays a critical role in the discovery and development of lifechanging 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.
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.
Job Description
Medical Writing acts as a strategic partner across drug discovery development and commercial teams. Medical Writing participates in crossfunctional drug discovery development and commercial product lifecycle management and contributes strategic expert input into scientific and regulatory content that is used for a variety of purposes including critical regulatory submissions. Medical Writing collaborates crossfunctionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world.
We have an exciting and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents independently including novel or atypical documents which require ingenuity and considerable medical writing expertise and autonomy. You will define the Medical Writing strategy plans and objectives for assigned products or projects. You will represent Medical Writing on relevant product project and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other crossfunctional initiatives. You may serve as the filing lead for large complex regulatory submissions and as lead medical writer for a large development program or TA. You will participate in or may lead Medical Writing and crossfunctional process improvement initiatives on regulatory document standards template development and document process. You may manage or supervise direct reports and contractors overseeing recruitment and onboarding.
EXAMPLE RESPONSIBILITIES:
- Authors a wide variety of documents of all types and complexities such as clinical study reports (CSRs) (all phases) investigator’s brochures CTD summaries/overviews PIPs/PIP modifications and regulatory responses.
- Typically represents Medical Writing and participates in multiple crossfunctional teams such as regulatory submissions and/or other regulatory project teams and provides guidance on regulatory submission document strategies.
- Plans and oversees all assigned deliverables. May serve as a filing lead for large complex regulatory submissions with responsibilities including development and management of document timelines and resource planning for assigned projects.
- May serve as a senior medical writer and department representative for a large development program or TA including providing guidance to less experienced Medical Writing colleagues or contractors working on the same projects.
- Participates in or may lead Medical Writing and crossfunctional process improvement initiatives on document standards template development and document processes.
- May also participate in other special projects and/or represent Medical Writing in other crossfunctional initiatives.
- Where applicable oversees the work of external contractors supporting Medical Writing deliverables and other activities.
- Typically coaches trains and provides guidance to less experienced Medical Writing colleagues. Leads or advises others on complex projects or problems with broad impact and reviews documents written by less experienced or contract medical writers.
- May manage one or more direct reports. Appropriately delegates projects and initiatives to team and identifies potential conflicts and proactively takes action to mitigate.
- Ensures own work complies with established practices policies and processes and any regulatory or other requirements.
We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
- PharmD/PhD with 6 years’ relevant experience.
- MA/MS/MPH/MBA with 8 years’ relevant experience.
- BA/BS with 10 years’ relevant experience.
- Significant medical writing regulatory quality clinical R&D or related experience in the biopharma industry.
- Proven track record in effectively setting and directing the medical writing or related strategy to successful conclusion for one or more products.
- Experience authoring a broad range of regulatory scientific and/or medical documentation across multiple stages of drug development.
- Significant experience participating in crossfunctional projects and teams with responsibilities related to clinical trials or other drug development activities.
- Demonstrated abilities to effectively delegate and manage others as evidenced through either past people management or matrix management responsibilities.
- Where applicable line management (direct reports) experience is preferred.
- Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.
BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry. Experience leading a broad range of medical writing or related deliverables and setting the medical writing or related strategy for biopharmaceutical products.
Knowledge & Other Requirements
- Recognized as a subject matter expert in a broad range of regulatory documentation and a resource for specialist advice and guidance.
- Demonstrates indepth knowledge of current global and regional trends in medical writing and regulatory and is able to apply this to advance and accelerate medical writing strategies for assigned products or projects.
- Thorough knowledge of the drug development process including all key functions involved in the various stages of drug development from early research through postmarketing.
- Demonstrates advanced regulatory and business knowledge and advanced analytical abilities as evidenced by strengths in assessing complex multidisciplinary data understand and effectively advise on its implications. Indepth knowledge of relevant health authorities including system processes and requirements.
- Able to advise crossfunctional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills.
- Strong negotiation and conflict resolution skills.
- When needed ability to travel.
For Additional Benefits Information Visit:
- Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.
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 nonjob 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.
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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Employment Type
Full Time
Key Skills
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