Senior Manager Medical Writing Oncology
Senior Manager Medical Writing Oncology
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$ 154020 - 199320
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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 Gileads product strategies and ensure successful licensure and maintenance of licensure of Gileads 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 senior level medical writer (Senior Manager Medical Writing Oncology) to join our dynamic team. You will author a wide range of regulatory documents independently including documents of high complexity. You will lead review and planning processes for multiple 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 will plan and have oversight for assigned medical writing deliverables and may serve as the filing lead for small to medium regulatory submissions. You will participate in process improvements new standards and updating document templates. You may coach train and provide guidance to less experienced Medical Writing colleagues. You may manage or supervise direct reports and contractors to ensure highest quality of medical writing and adherence to Gilead documents standards.
EXAMPLE RESPONSIBILITIES:
Authors a wide variety of documents of all types and complexities such as clinical study reports (CSRs all phases investigators brochures CTD summaries/overviews PIPs/PIP modifications and regulatory responses).
May represent Medical Writing in crossfunctional teams such as product project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent.
Plans and oversees assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects.
May serve as the filing lead for small to medium regulatory submissions.
May serve as lead medical writer and department representative across development programs.
Participates in development/improvement of document standards templates and processes and other nonmedical writing activities.
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 deliverables and other activities.
May coach train and provide guidance to less experienced Medical Writing colleagues.
May manage one or more direct reports.
Ensures own work complies with established practices policies and processes and any regulatory or other requirements.
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 4 years relevant experience.
MA/MS/MPH/MBA 6 years relevant experience.
BA/BS with 8 years relevant experience.
Significant medical writing regulatory quality clinical R&D or related experience supporting medicinal products.
Significant experience in the biopharma industry is strongly preferred.
Experience authoring a broad range of regulatory scientific and/or medical documentation across multiple stages of drug development.
Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.
Rest of World Education & Experience
BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry.
Knowledge & Other Requirements
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change to move between projects easily and provide support/expertise where needed.
Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance.
Indepth knowledge of relevant health authorities including system processes and requirements.
Indepth knowledge of regulatory document requirements and guidelines relevant to assigned products projects and markets as evidenced by effectiveness and successes authoring a broad range of regulatory documentation.
Able to advise crossfunctional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
Demonstrates strong analytical thinking skills attentiontodetail strong communication and writing skills project management skills and proficiencies with Microsoft Office suite as evidenced through accomplishments in past roles.
Ability to lead and influence programs projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Proven ability to work successfully in a teamoriented highly matrixed environment.
Capability to attend evening meetings as needed to support ROW submissions.
Significant oncology therapeutic area experience is strongly preferred.
When needed ability to travel.
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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 disabilitygenetic 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 theKnow Your Rights poster.
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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.
Required Experience:
Senior Manager
Employment Type
Full-Time
