Deciphera Pharmaceuticals, Inc
Director, Medical Writing
Deciphera Pharmaceuticals, Inc, Waltham, Massachusetts, us, 02453
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.See here for more details on our portfolio.Job Description This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science constantly evolving in light of new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.The Role:The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Medical Writing. The individual will be responsible for managing/mentoring a group of Regulatory Medical Writers as well as serve as lead writer across programs/submission that are part of the growing clinical pipeline.The position reports to the Executive Director, Medical Writing and Clinical Trial Disclosure.What You’ll Do:Build and mentor the regulatory Medical Writing teamOverall responsibility for planning, implementing, and adhering to medical writing timelines and budgets.Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentationAct as Lead Medical Writer for complex studies/documents such as master protocolsStrong team player and a change agent who further reinforces/enhances Deciphera’s cultural valuesExcellent people management skills – not only with direct reports but also with cross functional partners and broader organization and outside agenciesLead/participate in significant workstreams that involve work across departments and with external vendors; may include participation in initiatives such as document templates, development of CCI, writing style guide, and support for document reviewing/authoring toolsCoordinate and direct activities of protocol governance committeeExperience and skill performing medical literature searchesDeveloping and participating in department training and SOP developmentPerforming reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed.Act as subject matter expert for development of data transparency initiatives and lean writing conceptsMaintains cutting edge knowledge base of current developments in field and related technologiesRepresent Medical Writing in Inspection Readiness and participate in GCP Audits and InspectionsQualifications
Advanced degree (MS or Ph.D.) in a relevant scientific field. Ph.D. degree is preferredMinimum of 5-8 years medical writing experience with a total of more than 10 years of pharmaceutical or biotech experienceMinimum of 2-5 years experience managing people/MW CROsStrong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in planning and preparation of summary documentsExcellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracyExperience producing high quality clinical documentsKnowledge of clinical disclosureStrong organizational/prioritization skills for the management of multiple concurrent documentsDemonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please ReviewOncology experience is highly preferredAdditional Information We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here .We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:Patients –We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.Accountability –We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.Transparency –We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.Honesty and Integrity –Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.Stewardship –We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.“How” we work together and the behaviors that we show up with each dayarecritical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:Lead from where you are – regardless of role or level, we motivate each other to achieve common goals.Drive business results – we navigate forward with our eye on the highest priorities.Partner and collaborate – we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.Continuously evolve and improve – we try, we learn, we revise and try again.Deciphera offers a comprehensive benefits package that includes but is not limited to the following:Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.Family planning benefitGenerous parental leave[if applicable] Car allowanceEQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
#J-18808-Ljbffr
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.See here for more details on our portfolio.Job Description This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science constantly evolving in light of new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.The Role:The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Medical Writing. The individual will be responsible for managing/mentoring a group of Regulatory Medical Writers as well as serve as lead writer across programs/submission that are part of the growing clinical pipeline.The position reports to the Executive Director, Medical Writing and Clinical Trial Disclosure.What You’ll Do:Build and mentor the regulatory Medical Writing teamOverall responsibility for planning, implementing, and adhering to medical writing timelines and budgets.Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentationAct as Lead Medical Writer for complex studies/documents such as master protocolsStrong team player and a change agent who further reinforces/enhances Deciphera’s cultural valuesExcellent people management skills – not only with direct reports but also with cross functional partners and broader organization and outside agenciesLead/participate in significant workstreams that involve work across departments and with external vendors; may include participation in initiatives such as document templates, development of CCI, writing style guide, and support for document reviewing/authoring toolsCoordinate and direct activities of protocol governance committeeExperience and skill performing medical literature searchesDeveloping and participating in department training and SOP developmentPerforming reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed.Act as subject matter expert for development of data transparency initiatives and lean writing conceptsMaintains cutting edge knowledge base of current developments in field and related technologiesRepresent Medical Writing in Inspection Readiness and participate in GCP Audits and InspectionsQualifications
Advanced degree (MS or Ph.D.) in a relevant scientific field. Ph.D. degree is preferredMinimum of 5-8 years medical writing experience with a total of more than 10 years of pharmaceutical or biotech experienceMinimum of 2-5 years experience managing people/MW CROsStrong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in planning and preparation of summary documentsExcellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracyExperience producing high quality clinical documentsKnowledge of clinical disclosureStrong organizational/prioritization skills for the management of multiple concurrent documentsDemonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please ReviewOncology experience is highly preferredAdditional Information We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here .We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:Patients –We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.Accountability –We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.Transparency –We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.Honesty and Integrity –Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.Stewardship –We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.“How” we work together and the behaviors that we show up with each dayarecritical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:Lead from where you are – regardless of role or level, we motivate each other to achieve common goals.Drive business results – we navigate forward with our eye on the highest priorities.Partner and collaborate – we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.Continuously evolve and improve – we try, we learn, we revise and try again.Deciphera offers a comprehensive benefits package that includes but is not limited to the following:Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceESPP offeringHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.Family planning benefitGenerous parental leave[if applicable] Car allowanceEQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
#J-18808-Ljbffr