Senior Manager, Medical Writing Oncology
Locations: United Kingdom - Uxbridge, United Kingdom - Cambridge Job Description POSITION OVERVIEW: 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 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 cross-functional 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), investigator’s brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses. May represent Medical Writing in cross-functional 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 non-medical writing activities. 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 deliverables and other activities. May coach, train, and provide guidance to less experienced Medical Writing colleagues. May manage one or more direct reports. 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. 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. In-depth knowledge of relevant health authorities, including system, processes and requirements. In-depth 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 cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives. Demonstrates strong analytical thinking skills, attention-to-detail, 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 team-oriented, 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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Locations: United Kingdom - Uxbridge, United Kingdom - Cambridge Job Description POSITION OVERVIEW: 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 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 cross-functional 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), investigator’s brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses. May represent Medical Writing in cross-functional 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 non-medical writing activities. 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 deliverables and other activities. May coach, train, and provide guidance to less experienced Medical Writing colleagues. May manage one or more direct reports. 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. 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. In-depth knowledge of relevant health authorities, including system, processes and requirements. In-depth 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 cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives. Demonstrates strong analytical thinking skills, attention-to-detail, 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 team-oriented, 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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