Initial Therapeutics, Inc.
Associate Director, Medical Writing
Initial Therapeutics, Inc., San Mateo, California, United States, 94404
Associate Director, Medical Writing
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks. United States - California - Foster City United States – Remote United States - New Jersey - Parsippany
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
Job Description
Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional 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 cross-functionally 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 cross-functional 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 cross-functional process improvement initiatives on regulatory document standards, template development, and document process. You may manage or supervise direct reports and contractors, overseeing recruitment and on-boarding.
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 cross-functional 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 cross-functional 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 cross-functional 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.
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 cross-functional 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.
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 in-depth 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 post-marketing. 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. In-depth knowledge of relevant health authorities, including system, processes, and requirements. Able to advise cross-functional 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.
The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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 ApplicantAccommodations@gilead.com for assistance. #J-18808-Ljbffr
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks. United States - California - Foster City United States – Remote United States - New Jersey - Parsippany
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
Job Description
Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional 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 cross-functionally 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 cross-functional 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 cross-functional process improvement initiatives on regulatory document standards, template development, and document process. You may manage or supervise direct reports and contractors, overseeing recruitment and on-boarding.
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 cross-functional 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 cross-functional 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 cross-functional 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.
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 cross-functional 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.
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 in-depth 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 post-marketing. 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. In-depth knowledge of relevant health authorities, including system, processes, and requirements. Able to advise cross-functional 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.
The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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 ApplicantAccommodations@gilead.com for assistance. #J-18808-Ljbffr