Corcept Therapeutics
Associate Director, Scientific Communications
Corcept Therapeutics, Redwood City, California, United States, 94061
The Associate Director of Scientific Communications will play a crucial role in providing expert scientific and medical writing support to Clinical Development and cross-functional teams, including support for NDA/MAA submissions and launch planning. This position will also be responsible for developing and executing publication strategies, creating impactful science-driven communication platforms, and producing high-quality scientific and clinical abstracts, posters, presentations, and manuscripts.
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunityResponsibilities:Scientific Communications
Maintain advanced therapeutic area and product expertise through proactive review and analysis of available and emerging scientific/clinical evidence to support NDA/MAA and launch-planning activities and produce high quality publications.Provide scientific and medical writing support to cross-functional teams for NDA/MAA-related projects (e.g., briefing documents, draft labels, slide decks for meetings with regulatory agencies, etc.).Work with internal strategy teams, program leads, and external PIs/KOLs to develop high-impact publications (including abstracts, posters, manuscripts, and presentations) for Clinical Development-led studies that are scientifically accurate, relevant, and timely.Support the development of publications originating outside of Clinical Development, such as HEOR/RWE analyses, as needed.Support launch activities by collaborating with Medical Affairs teams to develop consistent, impactful communication strategies and provide training on published data.Establish credibility and build trust with external authors, internal stakeholders, and cross-functional team members to produce timely and high-quality documents.Provide support at key scientific congresses and meetings (including writing of session coverage reports, hanging posters, assisting with slide reviews with presenters).Assist in fact-checking documents against source data.Publication Strategy
Contribute to Publication Teams to develop and/or refresh therapeutic-area specific publication strategies, including scientific communication platforms, data generation plans, and publication plans.Develop and execute the publication plan to appropriately disseminate abstracts, posters, manuscripts, oral presentations, and other publications to inform external audiences.Contribute to and/or lead Publication Review Team meetings and publication strategy/brainstorming discussions, including proposing publication ideas.Perform literature searches and gap analyses to develop a robust publication plan in close collaboration with cross-functional Corcept stakeholders.Ensure alignment of the publications plan with all corporate policies and industry guidelines (ICMJE, GPP 2022).Publication Management
Manage all administrative/operational requirements of the publications plan, including chairing cross-functional Publication Team meetings and Publications Review Team meetings and managing the publications budget and vendors.Develop and/or provide guidance to vendors for the development of timelines for publications that adhere to Corcept’s procedures.Lead and manage the execution of publication plans across the product portfolio.Coordinate the review, approval, and other applicable activities related to the development of scientific publication projects.Policies and Procedures
Ensure publications are developed, reviewed, and approved according to Corcept’s policies and procedures.Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing and publications.Develop, enhance, and implement policies, procedures, and processes necessary to achieve organizational objectives and ensure compliance with Corcept and external (e.g., government, institutional) regulations.Preferred Skills, Qualifications and Technical Proficiencies:Work independently and collaboratively with cross-functional teams and external experts in a dynamic environment.Effectively adapt to changing business needs, conditions, and responsibilities.Prioritize and manage multiple tasks/projects in the face of ambiguity and achieve results on time.Excellent data analysis, synthesis, medical writing and editorial skills.Strong problem solving, influencing, and negotiation skills to build effective working relationships within Corcept and with external experts.Proven ability to write, edit, and prepare scientific publications (abstracts, posters, presentations, and manuscripts).Demonstrated ability to write effectively for and communicate with diverse audiences, including scientists, physicians, patients, and others.Solid understanding of the US healthcare environment, clinical trial/drug development, FDA and EMA regulations and other relevant guidelines.Proficient with online literature searches using a variety of professional tools/databases.Strong proficiency with Endnote (or equivalent), MS Office (Word, Excel, PowerPoint), Adobe Acrobat, scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems.Familiarity with electronic document management systems (e.g., Box, SharePoint) and publication tracking databases (e.g., PubsHub, Datavision).Preferred Education and Experience:Advanced scientific degree (e.g. M.S., Ph.D., PharmD) preferred.6+ years of related work experience in the pharmaceutical industry in medical affairs, publications, and/or medical communications.Knowledge of GPP 2022 and ICMJE industry guidelines (CMPP certification desired).Experience in publication planning.Previous experience in endocrinology or oncology preferred.Experience with regulatory writing (especially NDA/MAA-related documents) preferred.The pay range that the Company reasonably expects to pay for this position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.Applicants must be currently authorized to work in the United States on a full-time basis.
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Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunityResponsibilities:Scientific Communications
Maintain advanced therapeutic area and product expertise through proactive review and analysis of available and emerging scientific/clinical evidence to support NDA/MAA and launch-planning activities and produce high quality publications.Provide scientific and medical writing support to cross-functional teams for NDA/MAA-related projects (e.g., briefing documents, draft labels, slide decks for meetings with regulatory agencies, etc.).Work with internal strategy teams, program leads, and external PIs/KOLs to develop high-impact publications (including abstracts, posters, manuscripts, and presentations) for Clinical Development-led studies that are scientifically accurate, relevant, and timely.Support the development of publications originating outside of Clinical Development, such as HEOR/RWE analyses, as needed.Support launch activities by collaborating with Medical Affairs teams to develop consistent, impactful communication strategies and provide training on published data.Establish credibility and build trust with external authors, internal stakeholders, and cross-functional team members to produce timely and high-quality documents.Provide support at key scientific congresses and meetings (including writing of session coverage reports, hanging posters, assisting with slide reviews with presenters).Assist in fact-checking documents against source data.Publication Strategy
Contribute to Publication Teams to develop and/or refresh therapeutic-area specific publication strategies, including scientific communication platforms, data generation plans, and publication plans.Develop and execute the publication plan to appropriately disseminate abstracts, posters, manuscripts, oral presentations, and other publications to inform external audiences.Contribute to and/or lead Publication Review Team meetings and publication strategy/brainstorming discussions, including proposing publication ideas.Perform literature searches and gap analyses to develop a robust publication plan in close collaboration with cross-functional Corcept stakeholders.Ensure alignment of the publications plan with all corporate policies and industry guidelines (ICMJE, GPP 2022).Publication Management
Manage all administrative/operational requirements of the publications plan, including chairing cross-functional Publication Team meetings and Publications Review Team meetings and managing the publications budget and vendors.Develop and/or provide guidance to vendors for the development of timelines for publications that adhere to Corcept’s procedures.Lead and manage the execution of publication plans across the product portfolio.Coordinate the review, approval, and other applicable activities related to the development of scientific publication projects.Policies and Procedures
Ensure publications are developed, reviewed, and approved according to Corcept’s policies and procedures.Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing and publications.Develop, enhance, and implement policies, procedures, and processes necessary to achieve organizational objectives and ensure compliance with Corcept and external (e.g., government, institutional) regulations.Preferred Skills, Qualifications and Technical Proficiencies:Work independently and collaboratively with cross-functional teams and external experts in a dynamic environment.Effectively adapt to changing business needs, conditions, and responsibilities.Prioritize and manage multiple tasks/projects in the face of ambiguity and achieve results on time.Excellent data analysis, synthesis, medical writing and editorial skills.Strong problem solving, influencing, and negotiation skills to build effective working relationships within Corcept and with external experts.Proven ability to write, edit, and prepare scientific publications (abstracts, posters, presentations, and manuscripts).Demonstrated ability to write effectively for and communicate with diverse audiences, including scientists, physicians, patients, and others.Solid understanding of the US healthcare environment, clinical trial/drug development, FDA and EMA regulations and other relevant guidelines.Proficient with online literature searches using a variety of professional tools/databases.Strong proficiency with Endnote (or equivalent), MS Office (Word, Excel, PowerPoint), Adobe Acrobat, scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems.Familiarity with electronic document management systems (e.g., Box, SharePoint) and publication tracking databases (e.g., PubsHub, Datavision).Preferred Education and Experience:Advanced scientific degree (e.g. M.S., Ph.D., PharmD) preferred.6+ years of related work experience in the pharmaceutical industry in medical affairs, publications, and/or medical communications.Knowledge of GPP 2022 and ICMJE industry guidelines (CMPP certification desired).Experience in publication planning.Previous experience in endocrinology or oncology preferred.Experience with regulatory writing (especially NDA/MAA-related documents) preferred.The pay range that the Company reasonably expects to pay for this position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.Applicants must be currently authorized to work in the United States on a full-time basis.
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