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Proposal Writing Specialist

Highmark Health
4870 Forbes Ave, Pittsburgh, PA 15289

Job DescriptionJOB SUMMARY\n\nThis job is responsible for the development, writing, planning, design, and delivery of customer-focused requests for proposals and information that supports the organization's strategic sales objectives. The incumbe... Read More

Job DescriptionJOB SUMMARY\n\nThis job is responsible for the development, writing, planning, design, and delivery of customer-focused requests for proposals and information that supports the organization's strategic sales objectives. The incumbent is responsible for consulting with all levels of management to proactively identify and develop a win strategy that communicates and demonstrate he value of the organization (i.e. products, services, initiatives and overall brand, mission, vision, and strategic direction). The incumbent is responsible to develop project plans within tight deadlines that require cross-functional collaboration and management of interdependencies and/or related activity within the constraint of scope, quality and time. Reviews complex technical information across multiple product lines of business to translate into information that is customized, persuasive, and relatable for clients, consultants, and Partner Plans. Supports sales goals of growth and retention for small, mid-market, national, government clients and expanded Blue partnerships. Solves problems, taking broad perspective to develop innovative solutions that influence the Enterprise's reputation with internal and external customers, and relationships with national consultants and partner plans, with minimal management support.\n\nESSENTIAL RESPONSIBILITIES\n\nDevelop, plan, research, write, edit, manage, and deliver complex requests for proposals and information. Demonstrate subject-matter knowledge of all lines of business, products and services in order to develop clear and concise messaging and provide subject-matter direction to complete projects and assignments. Solid knowledge of the Organization's distribution channels. Conduct market research, trend analysis to interpret and understand the needs of the customer in order to create a compelling, well-articulated value proposition that aligns the organization's products/services with the customers' healthcare strategy. Write and create compelling, well-articulated value proposition that aligns the Organization's products/services with the customers' health strategy. Tailor product information and positioning that are appropriate for the intended audience that is understandable, persuasive, and customized (written and visual) with targeted, strategic solutions according to project timeliness. Provide quality review of messaging to ensure accuracy, consistency, appropriate position and competitive differentiation.\nProject manage for high exposure , critical impact projects related to sales activity and manage all phases of proposal process. Manage and lead kick-off, work with key stakeholders to drive client strategy and approach. Effectively communicate the RFP strategy to a network of SMEs, copywriters, and creative specialists, to ensure projects are completed in the same "voice," and reflect the strategy that has been developed with sales leaders. Organize, plan, and maintain project plan with tight deadlines. Manage multiple projects simultaneously. Anticipate roadblocks, monitor and evaluate to deliver custom, differentiated, innovative solutions and value proposition proposals that are accurate, on message and brand, by specified deadlines.\nFacilitate strategic planning meetings with all levels of the organization to develop strategy, customized solutions. Includes proactive planning to advance leaders through strategic planning to develop central strategy for RFPs in advance of RFP, during RFP, and/or providing expert market intelligence on RFP trends. Communicate effectively and serve as trusted adviser/consultative partner internally (sales, SMEs, senior leadership) and externally (consultants, Blues Plans) to resolve problems and prioritize solutions.\nCreate, research, develop, write, and manage other sales information resources: executive summaries, white papers, factoids, case studies/testimonials, and other ad-hoc requests to be used for sales staff to respond to customer needs in a customized solution-sales driven market.\nMaintain detailed records and facilitate proper record submission for new/updated content for database administrator. Use Sales Tools efficiently and appropriately to provide custom reports. Apply knowledge of graphic standards, brand requirements, to materials, as appropriate, adhering to company policies and procedures.\nOther duties as assigned\nEDUCATION\n\nRequired\n\nBachelor's Degree in Marketing, Journalism, Technical Writing, Public Relations, or English OR 6 years of relevant Marketing, Messaging, Request for Proposal management experience in lieu of Bachelor's Degree\nEXPERIENCE\n\nRequired\n\n3 - 5 years of Bid/Proposal Writing, Project Management, Communications, Marketing Communications, or Sales Support experience\nPreferred\n\n3 -5 years of experience in the Healthcare Industry or Health Insurance Industry\nLICENSES OR CERTIFICATIONS\n\nPreferred\n\nCertified Healthcare Business Consultant (CHBC)\nAPMP Certification\nAmerica's Hea

Medical Writing Manager

i-hire
4053 Brooks Ct, Pleasanton, CA 94588

Overall, the Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effe... Read More

Overall, the Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to SOPs, regulatory requirements and submission-specific requirements. Medical Writers will work closely with internal project-level SMEs (e.g., Medical and Scientific Affairs, Clinical Operations, Regulatory Affairs, Biostatistics, R&D, etc.) and external SMEs (e.g., customers, KOLs, etc.) that are responsible for generating, changing and/or updating scientific content. Accountable for and manages day-to-day activities of the Medical Writing team, such as assignment delegation, performance reviews, professional development/coaching, budgeting and time-tracking, process improvement, document standardization and KPI reporting/tracking. Independently leads process improvement initiatives, such as updating SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc. Periodically communicates team activities, progress, and goals to leadership through one-on-one (e.g., in-person meetings, emails) and group communications (e.g., PowerPoint presentations) For selected and high priority medical documents, will serve as primary point of contact with oversight and management responsibility for the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals), and submission (interface with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.) Partners with the Publications Manager to assign (to the Medical Writing team) and complete selected Scientific Communications. Collaborates with other Medical Writing teams within Roche to share best practices, harmonize documents and improve related processes/procedures. Effectively communicates and builds healthy working relationships with Medical Writing team members and key stakeholders throughout the organization with whom he/she will work closely. Actively participates in Medical Writing team meetings and activities. Successfully completes all assigned curricula and on-the-job training modules. Performs his/her work in accordance with corporate cultural beliefs and agreed upon Key Performance Indicators (KPIs). Provides appropriate and transparent notification for work absences. Required: Master's degree in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields English proficiency (both spoken and written) Preferred: Doctoral degree or higher (e.g., PhD, PharmD, DVM) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields English as a primary language Experience: 5 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports. Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA). Supervisory and/or project management experience Submission and publication management of scientific manuscripts to at least 5 different journals Preferred 10 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports. Submission and publication management of scientific manuscripts to at least 10 different journals Experience with in vitro diagnostics, molecular diagnostics and/or Infectious Disease Knowledge of drug development (e.g., pharmacokinetics, biostatistics, nonclinical and clinical research) Process improvement and/or Six Sigma training Knowledge, Skills, and Abilities: Knowledge and understanding of the clinical research process, including ICH GCP and FDA regulations Knowledge on Good Publication Practices Experience in working with Templates, Style Guides, SharePoint and Document Management Tools Calendar management skills/ expertise using Google Calendar Reference management skills/ expertise with EndNote (preferred) or equivalent Meticulous attention to detail Strong interpersonal and communication skills, including conflict resolution and influencing Comfortable with virtual work environments and meetings Ability to work effectively in a fast-paced environment and with multiple high priority projects Ability to problem solve and delegate appropriate tasks to collaborators and follow-up as needed to meet - provided by Dice5+ years scientific research and/or medical writing experience Associated topics: emergency department, emt, emt i, emt p, medic, slh, technician, technician iii, technician emergency, transport

Writing Systems Engineer

HP
San Diego, CA 92140

At HP, talent is our criteria. Join us in reinventing the standard for diversity and inclusion. Bring your awesomeness, and just be you! Applies basic foundation of a function's principles, theories and concepts to assignments of limited scope. Uses... Read More

At HP, talent is our criteria. Join us in reinventing the standard for diversity and inclusion. Bring your awesomeness, and just be you! Applies basic foundation of a function's principles, theories and concepts to assignments of limited scope. Uses professional concepts and theoretical knowledge acquired through specialized training, education or previous experience. Develops expertise and practical knowledge of applications within business environment. Acts as team member by providing information, analysis and recommendations in support of team efforts. Exercises independent judgment within defined parameters. Responsibilities: * Designs portions of engineering solutions for electrical and electronic parts, subsystems, integrated circuitry, and algorithms based on established engineering principles and in accordance with provided specifications and requirements. * Implements established test plans for existing designs, including validation of tolerances, form/fit/function, shock and vibration, electromagnetic interference, safety, reliability, thermal generation, and system power measurements. * Develops understanding of and relationship with internal and outsourced development partners on electrical hardware design and development. * Participates as a member of project team of other electrical hardware engineers and internal and outsourced development partners to develop reliable, cost effective and high quality solutions for low to moderately- complex products. Education and Experience Required: * Bachelor's or Master's degree in Engineering. Typically 0-2 years experience. Knowledge and Skills: * Experience or understanding of electrical design tools and software packages. * Good analytical and problem solving skills. * Understanding of design for electronic components, integrated circuitry, and algorithms. * Understanding of thermal and electromagnetic properties of materials and managing emissions. * Good written and verbal communication skills; mastery in English and local language.SDL2017

Katy Writing Tutor Jobs

Varsity Tutors
2702 Washington Ave, Houston, TX 77251

Katy Writing Tutor JobsVarsity Tutors has students in Katy looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clien... Read More

Katy Writing Tutor JobsVarsity Tutors has students in Katy looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: child care, company, dance, driving, driving school, gre, summer, violin, voice, weapons

Medical Writing Manager

SigmaWays
4215 Casterson Ct, Pleasanton, CA 94566

Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and ass... Read More

Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to RMS SOPs, regulatory requirements and submission-specific requirements. Medical Writers will work closely with internal project-level SMEs (e.g., Medical and Scientific Affairs, Clinical Operations, Regulatory Affairs, Biostatistics, R&D, etc.) and external SMEs (e.g., customers, KOLs, etc.) that are responsible for generating, changing and/or updating scientific content. ESSENTIAL RESPONSIBILITIES: Accountable for and manages day-to-day activities of the Medical Writing team, such as assignment delegation, performance reviews, professional development/coaching, budgeting and time-tracking, process improvement, document standardization and KPI reporting/tracking. Independently leads process improvement initiatives, such as updating RMS SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc. Periodically communicates team activities, progress, and goals to leadership through one-on-one (e.g., in-person meetings, emails) and group communications (e.g., PowerPoint presentations) For selected and high priority medical documents, will serve as primary point of contact with oversight and management responsibility for the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals), and submission (interface with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.) Partners with the RMS Publications Manager to assign (to the Medical Writing team) and complete selected Scientific Communications. Collaborates with other Medical Writing teams within to share best practices, harmonize documents and improve related processes/procedures. Effectively communicates and builds healthy working relationships with Medical Writing team members and key stakeholders throughout the organization with whom he/she will work closely. Actively participates in Medical Writing team meetings and activities. Successfully completes all assigned curricula and on-the-job training modules. Provides appropriate and transparent notification for work absences. MINIMUM QUALIFICATIONS: 5 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports. Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA). Supervisory and/or project management experience Submission and publication management of scientific manuscripts to at least 5 different journals Master's degree in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields English proficiency (both spoken and written) Preferred 10 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports. - provided by Diceoversees and manages the entire document and submission lifecycle,SOPs/procedures,regulatory requirements Associated topics: hematopathology, laboratory, medical lab science, microbiology, molecular, scientist, services, technician laboratory, technologist, toxicology

McKinney Writing Tutor Jobs

Varsity Tutors
3808 Mockingbird Ln, Dallas, TX 75205

McKinney Writing Tutor JobsVarsity Tutors has students in McKinney looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writin... Read More

McKinney Writing Tutor JobsVarsity Tutors has students in McKinney looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: child care, dance, evening, extra, horse, instructor, lsat, muse, violin, voice

Denver Writing Tutor Jobs

Varsity Tutors
Denver, CO 80217

Denver Writing Tutor JobsVarsity Tutors has students in Denver looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, c... Read More

Denver Writing Tutor JobsVarsity Tutors has students in Denver looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: after school, cooking, driver, equestrian, gre, instructor, painting, piano, shooting, violin

Paterson Writing Tutor Jobs

Varsity Tutors
326 W 45th St, New York, NY 10036

Paterson Writing Tutor JobsVarsity Tutors has students in Paterson looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writin... Read More

Paterson Writing Tutor JobsVarsity Tutors has students in Paterson looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: cooking, driving, driving school, equestrian, evening, gre, gymnastics, summer, violin, voice

Senior Director Clinical Writing

JGB BioPharma Consulting
San Francisco, CA 94101

Requirements:Ability to work independently with little supervisionAbility to optimize and standardize writing practices forthe companyHas utilized and understands ICMJE, GPP writing guidesPreviously participated in writing / editing of peer reviewed ... Read More

Requirements:Ability to work independently with little supervisionAbility to optimize and standardize writing practices forthe companyHas utilized and understands ICMJE, GPP writing guidesPreviously participated in writing / editing of peer reviewed scientific journal articles. Comprehends medical scientific data. Previously held leadership position as a Medical Writer in a pharmaceutical company. Has experience with standard clinical documents such as Investigator Brochures, Clinical Study Reports, and the clinical sections of regulatory submissions. Experience with confidential data Ability to work with both internal and external personnel in a collaborative fashion. Ability to interact well with KOLs and to work in a fast paced environment. Project management of document flow from origin to completion. Ensure the creation of high quality final documents by monitoring writing from draft to finalizationMeet timelines for submission of specific documents. Write or edit documents as required. Develop synopsis of complex data as an abstract or for a visual display ensuring that key messages are clear. Search and obtain key journal articles for review by team and use as references in written documents.Formulate writing templates for use by team members Associated topics: editor, editor writer, fda, law, medical writer, regulatory, regulatory affairs, scientific journal, write, writer

Anaheim Writing Tutor Jobs

Varsity Tutors
1707 Hillcrest Dr, Beverly Hills, CA 90210

Anaheim Writing Tutor JobsVarsity Tutors has students in Anaheim looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing,... Read More

Anaheim Writing Tutor JobsVarsity Tutors has students in Anaheim looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: child care, dancing, driver, driving school, extracurricular, instructor, salsa, shooting, sierra club, voice

Associate Director, Medical Writing

Ultragenyx Pharmaceuticals
1574 S Novato Blvd, Novato, CA 94998

Why Join Us? Be a hero for our rare disease patients Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule... Read More

Why Join Us? Be a hero for our rare disease patients Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission ? to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities! Position Summary: ultrafocused ? Work together to fearlessly uncover new possibilities The Associate Director, Medical Writing will be responsible for writing and overseeing the writing of various clinical and regulatory documents, including distribution of work to contract medical writers or agencies as needed. This is an individual contributor position with team leadership responsibilities. The Associate Director, Medical Writing will work closely with cross-functional teams to ensure the documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The core duties of the Associate Director, Medical Writing are delineated below. Responsibilities, including but not limited to: * Write, edit, or collaborate on development of high-quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books) * Contribute scientifically and strategically and lead submission-level activities for writing team * Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) * Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives and/or contract writers as required and ensure adherence to standards * Distill large amounts of clinical and scientific data into essential elements for graphical display * Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams * May interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses. * Formulate key messages from clinical study data * Perform literature-based research to support writing activities * Develop best practices for authoring and reviewing * Develop and maintain templates and outlines for key documents Requirements: * BS, MS, or doctorate in a scientific or medical field * Six+ years in the biotechnology/pharmaceutical industry including in-house experience preferred * Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus. * Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support * Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects * Experience analyzing and communicating scientific data in peer-reviewed scientific publications and knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices a plus * Rare disease experience and/or experience in bone disease a plus Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: ...@ultragenyx.com. #LI-YG1SDL2017 Associated topics: administrative, administrative assistant, administrative support, beverage, chief operations officer, document, front office, operational assistant, operations director, staff

Oxnard Writing Tutor Jobs

Varsity Tutors
1707 Hillcrest Dr, Beverly Hills, CA 90210

Oxnard Writing Tutor JobsVarsity Tutors has students in Oxnard looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, c... Read More

Oxnard Writing Tutor JobsVarsity Tutors has students in Oxnard looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: cooking, dancing, gardening, gmat, gre, music, piano, shooting, sierra club, summer

Assoc Dir, Medical Writing

Alexion Pharmaceuticals
Boston, MA 02298

Position Summary This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will lead the medical writing (MW) activities across a disease area or set of ... Read More

Position Summary This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with moderate supervision. The scope of this position includes the writing, document management, and development support for clinical study-related documentation including, but not limited to, clinical study protocols, Investigator's Brochures, and clinical study reports; and to collaborate with cross-functional teams to write and development regulatory submission documents, risk management plans, briefing books, regulatory response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents. Principal Responsibilities * Authors and manages the completion of clinical documents and other assigned tasks within established timelines with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Clinical document types include clinical study protocols, clinical study reports, Investigator's Brochures and updates, clinical Common Technical components (includes Module 2 summaries), risk management plans, contributions to briefing books, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents. * Supports development and implementation of strategy for writing and completion of high quality clinical documents. * Actively supports clinical project team(s), representing MW, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary. * Participates with other MW team members to develop and support process and standards to be implemented, and takes responsibility for execution across cross functional teams. * Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues. * Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations. * Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards. * Ensures that all activities are conducted in compliance with relevant regulatory requirements. Qualifications * At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge * Experience with global trials and regulatory submissions preferred * Experience with partnering and managing CRO relationships a plus * Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projects * Experience desired in MW for rare diseases and capability to develop and implement innovative solutions for optimizing MW for rare disease studies * Demonstrated writing capability for clinical study documents, (eg, clinical study protocols and clinical study reports, Investigator's Brochures) * Demonstrated capability to accurately present clinical study data within the context of a specific type of clinical document. * Excellent oral, written, and presentation skills * Thorough knowledge of global regulatory requirements and ICH/GCP guidelines * Ability to establish excellent internal and external relationships, including alliance partners and vendors * Excellent project management skills, with emphasis on time management and timelines, and * administrative skills * Excellent problem solving, organizational, and negotiating skills * Team player who thrives in a team-based environment * Well-developed sense of ethics, responsibility, and respect for others * Agile learner with ability to work both collaboratively or independently, seeking advice as required. * Results- and compliance-driven; sets standard of excellence for self and others * High level of flexibility and ability to innovate and adapt to changing conditions Education * MS degree in life sciences or equivalent required; advanced degree in a relevant * LI-FC1 Boston, MA, United States Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com. As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.SDL2017 Associated topics: care, clinic, family, family medicine, family practice, family practice physician, outpatient, physician, practitioner, primary

Alpharetta ACT Writing Tutor Jobs

Varsity Tutors
6 Eagle Row, Atlanta, GA 30322

Alpharetta ACT Writing Tutor JobsVarsity Tutors is always looking for bright individuals in Alpharetta who are passionate about mentoring others. Aside from having knowledge in a subject area, tutors should also be friendly, articulate, and punctual.... Read More

Alpharetta ACT Writing Tutor JobsVarsity Tutors is always looking for bright individuals in Alpharetta who are passionate about mentoring others. Aside from having knowledge in a subject area, tutors should also be friendly, articulate, and punctual. Working with Varsity Tutors in Alpharetta includes several benefits, such as the flexibility to schedule your own sessions , and to set your own tutoring load. We put forth great effort to match students to the right tutors, resulting in relationships that provide for great learning environments. What do we look for in a tutor? Excellent communication skills and a friendly personality Academic background in subject areas you wish to tutor Ability to personalize lessons for each student Associated topics: dance, equestrian, extracurricular, jrotc, lsat, mcat, salsa, tutor, violin, weapons

Del Mar Writing Tutor Jobs

Varsity Tutors
5002 Carmel Knolls Dr, San Diego, CA 92130

Del Mar Writing Tutor JobsVarsity Tutors has students in Del Mar looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing,... Read More

Del Mar Writing Tutor JobsVarsity Tutors has students in Del Mar looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: after school, chess, driver, extra, extracurricular, horse, sat, tutor, violin, weekend

Grandview Writing Tutor Jobs

Varsity Tutors
5 W 19th St, Kansas City, MO 64141

Grandview Writing Tutor JobsVarsity Tutors has students in Grandview looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writ... Read More

Grandview Writing Tutor JobsVarsity Tutors has students in Grandview looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: dance, equestrian, extracurricular, horse, jrotc, mcat, muse, piano, tutor, voice

Bellevue Writing Tutor Jobs

Varsity Tutors
401 Yesler Way, Seattle, WA 98104

Bellevue Writing Tutor JobsVarsity Tutors has students in Bellevue looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writin... Read More

Bellevue Writing Tutor JobsVarsity Tutors has students in Bellevue looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: company, cooking, driver, driving school, evening, guitar, horse, lsat, music, shooting

Springfield Writing Tutor Jobs

Varsity Tutors
3810 Powelton Ave, Philadelphia, PA 19104

Springfield Writing Tutor JobsVarsity Tutors has students in Springfield looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in ... Read More

Springfield Writing Tutor JobsVarsity Tutors has students in Springfield looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: ballroom, dance, driving, extra, guitar, incorporated, instructor, music, sierra club, weapons

Wayne Writing Tutor Jobs

Varsity Tutors
326 W 45th St, New York, NY 10036

Wayne Writing Tutor JobsVarsity Tutors has students in Wayne looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, cli... Read More

Wayne Writing Tutor JobsVarsity Tutors has students in Wayne looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: after school, company, dance, driver, gmat, guitar, incorporated, piano, rotc, summer

Vista Writing Tutor Jobs

Varsity Tutors
5002 Carmel Knolls Dr, San Diego, CA 92130

Vista Writing Tutor JobsVarsity Tutors has students in Vista looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, cli... Read More

Vista Writing Tutor JobsVarsity Tutors has students in Vista looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: ballroom, cooking, driving, extracurricular, gmat, guitar, gymnastics, mcat, sierra club, weapons