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Associate Director, Medical Writing

Amicus Therapeutics
142 Plainsboro Rd, Cranbury, NJ 08512

Position SummaryAmicus Therapeutics is a biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We are looking to hire an experienced medical writing lead to be based at our headquarters... Read More

Position SummaryAmicus Therapeutics is a biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We are looking to hire an experienced medical writing lead to be based at our headquarters in Cranbury, NJ. This Associate Director, Medical Writing will report to the Senior Director of Medical Writing. This individual works in partnership with the senior management of the Medical Writing Department and is the primary overseer and performer for the medical writing activities that support one or more Amicus clinical development programs. The person(s) in this role will both manage other writers (including Amicus and contract/CRO employees) and work directly on documents/projects with cross-functional teams. The individual will serve as the medical writing expert for a program and collaborate with internal staff across various departments (eg, Global Regulatory Affairs, Clinical Research, Clinical Operations, Data Management, and Statistics). Roles and ResponsibilitiesServing as the Medical Writing Lead for one or more Amicus clinical development programsWithin assigned programs, developing a comprehensive understanding of study designs, objectives, analysis plans, and resultsEnsuring that documents prepared are appropriate for their target audience while also meeting all regulatory requirementsCompose, revise in response to team feedback, and deliver submission-ready documents (eg, key clinical study protocols, briefing documents, overall summary documents)Performing document-specific tasks such as (a) Drafting or overseeing clinical study reports, (b) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells, (c) ensuring editorial review of documents (grammar, punctuation, and formatting), and (d) ensuring quality-checking of documents (including for submission-ready formatting)Manage, lead, and/or assist more junior writers and other medical writing-related staff (including contract or CRO staff)Provide detailed, accurate, and timely reviews of documents prepared by others (eg, Statistical Analysis Plans, Clinical Study Reports, Investigator Brochure Updates, Developmental or Periodic Safety Update Reports)Providing training and guidance on medical writing best practicesEnsuring compliance in regard to use of document templates and following standard operating procedures (SOPs), including applying the principle of continuous improvement to all in-house and contracted medical writing proceduresCollaborating with subject matter experts across other Amicus functionsContributing to clinical development team meetings, with a focus on resolving issues related to regulatory document planning, development, and approvalPlanning and conducting cross-functional meetingsBuilding and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the overall medical writing community)Contributing to medical writing vendor selection, contracting, and managementParticipating in departmental oversight, including projection of annual budget and resource needsKeeping informed of new regulations and/or guidance from regulatory authoritiesExperience across most types of regulatory medical writing deliverablesMust be able to plan activities of self and others, and manage the deliverables of others in accordance with pre-established timelines, while systematically performing activities in a timely and accurate manner Demonstrated ability to independently make and execute strategic decisions, based on quickly digesting and assimilating pertinent information, and including leading cross-functional teams through executionAbility to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demandsDemonstrated ability to translate technical information from mixed sources into written information suitable for an audience of clinicians and regulatory authorities while summarizing data that enables reaching conclusions and exercising judgment to move projects forward Training in the biomedical sciences, as well as experience in technical written communication and working cross-functionally, including with partner companies and vendorsAdvanced writing and speaking competencyPositive and proactive communication skills, including effective meeting planning and managementExperience in managing junior colleagues, including supporting their career developmentExperience in selecting, contracting, and managing contract writers/ writing vendorsProficiency with the Microsoft Office Suite, including MSProjectDemonstrated high attention to detail, including capacity to catch and resolve issues not caught by more junior level quality checkingRequirementsThe ideal candidate will possess a graduate level educationA minimum of 4 to 8 years experience with related work within a pharmaceutical company or CRO; all clinical or clinical research experience will be consideredLocationThis position will be based at 1 Cedar Brook Drive, Cranbury, NJ, 08512Majority of time (eg, 3 of every 5 days) are to be onsiteTravel0-5% Travel is required for this position Associated topics: administrative, administrative support, assist, associate, front desk, operation, operational assistant, operations director, records management, support

Sr. Director, Medical Writing

Confidential
101 Auburn St, Cambridge, MA 02139

Tracking Code 8R-13 Job Description The Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissio... Read More

Tracking Code 8R-13 Job Description The Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissions. The Senior Director, Medical Writing must ensure that quality systems and processes are in place to support the author, review, and approval of documents and ensure appropriate templates are in place for documents such as, but not limited to, Clinical Study Reports, Protocols and Investigator Brochures and other documents necessary for regulatory submissions. This position must ensure appropriate planning and orchestration of writ ... Associated topics: administrative, administrative assistant, administrative coordinator, beverage, document, facilities, food, operation, operational assistant, operations director

Assoc Dir, Medical Writing

Confidential
746 Washington St, Dorchester Center, MA 02124

Assoc Dir, Medical Writing Req ID: 14212 Job Category: Clinical Operations Location: Boston, MA Posting Date: August 14, 2018 Position Summary This position is accountable for the timely preparation of high quality, regulatory-compliant clinica... Read More

Assoc Dir, Medical Writing Req ID: 14212 Job Category: Clinical Operations Location: Boston, MA Posting Date: August 14, 2018 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 ...

Associate Director Regulatory Writing

JGB BioPharma Consulting
San Francisco, CA 94101

Requirements:Bachelors degree in a science discipline with a minimum of 7 years medical writing experience in a Pharmaceutical company or Advanced Degree with 4 years medical writing experience in a pharmaceutical, clinical or laboratory settingExcel... Read More

Requirements:Bachelors degree in a science discipline with a minimum of 7 years medical writing experience in a Pharmaceutical company or Advanced Degree with 4 years medical writing experience in a pharmaceutical, clinical or laboratory settingExcellent understanding of the drug development processRegulatory writing experience for NDA submissions preferredGood understanding of experimental methods, research design, and statistical analysis.Ability to analyze medical data and interpret its significance within a pharmaceutical setting.Ability to interpret, analyze, and present statistical data obtained in a clinical trial.Advanced scientific, technical reading, writing and editing skills.Excellent oral communication skills.Proficient computer and word processing skills.Description: Reviewing analyses and data presentations to be used in study reports or other documents.Providing input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines.Ensuring that all clinical documents are produced according to appropriate SOPs and business practices.Supervising contract medical writersResearching, writing, and managing: IBs, clinical study reports, abstracts, posters, publications, clinical summaries, clinical overviews, protocols, protocol amendments, annual safety updates, and presentations.Developing, implementing and using templates and guidelines for clinical documentation. Potentially providing template training to teams.Reviewing pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.Supporting clinical teams in protocol and CRF development.

Group Head, Regulatory Writing

Confidential
38 Deforest Ave, East Hanover, NJ 07936

243254BR Group Head, Regulatory Writing Job Description The Group Head, Regulatory Writing will manage a team of Regulatory Writing associates and collaborate with other RWS Groups and Function Heads to coordinate the timely production of hi... Read More

243254BR Group Head, Regulatory Writing Job Description The Group Head, Regulatory Writing will manage a team of Regulatory Writing associates and collaborate with other RWS Groups and Function Heads to coordinate the timely production of high quality deliverables. Major Responsibilities: 1. Functional and Operational Manager for a group of associates. 2. Oversee day-to-day operations for group of associates and ensure adequate staffing of programs. 3. Ensure high quality and timely delivery of tasks/projects assigned to Group. 4. Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Global/Unit Head. 5. Interact ...

Manager, Tech Writing & Comms

Confidential
7701 44th Ave NE, Seattle, WA 98115

Manager, Tech Writing & Comms Manager, Tech Writing & Comms LocationUS-WA-Seattle Posted Date8 hours ago(8 hours ago) Job ID 716896 Company Amazon.com Services, Inc. Position Category Editorial, Writing, & Content Management Job D... Read More

Manager, Tech Writing & Comms Manager, Tech Writing & Comms LocationUS-WA-Seattle Posted Date8 hours ago(8 hours ago) Job ID 716896 Company Amazon.com Services, Inc. Position Category Editorial, Writing, & Content Management Job Description Amazon s Engineering Excellence (EE) group drives technical and leadership skills across Amazon s engineering community. We provide Amazon engineers, the information they need to build the products and services that delight customers. We are looking for a talented manager to lead our team of Technical Writers. Our team of talented writers develop content to inspire and ...

Associate Director, Medical Writing

Alkermes
330 Winter St, Waltham, MA 02451

We have the need for a highly collaborative, Associate Director, Medical Writing to join our team based in Waltham, MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure adherenc... Read More

We have the need for a highly collaborative, Associate Director, Medical Writing to join our team based in Waltham, MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure adherence to GCP, ICH guidelines, and Alkermes SOPs.KEY DUTIES:Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, and ProjectManagement in planning and preparation of clinical and regulatory documentsAct as Lead Medical Writer at Project level in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPsRepresent Medical Writing on cross-functional clinical teams and actively participate in NDA submission planning and documentationPlan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time framesMentor junior Medical WritersTECHNICAL SKILLS: Experience in clinical documents related to late phase studies.NDA experience with active contribution in planning and preparation of summary documents is required.Facilitate Clintrials.Gov results postingsPERSONAL SKILLS:Ability to independently plan and prepare Clinical and Regulatory DocumentsExcellent interpersonal and communication skillsFlexibility/adaptability to work in a fast-paced and dynamic environmentProficient with MS Office and other related software programsExperience in managing people and projectsExperience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame MINIMUM EDUCATION AND EXPERIENCE:Bachelors Degree; Advanced degree (MS or Ph.D.) in a relevant scientific field preferred10+ years of industry experience as Medical WriterParticipation as writing lead on at least one NDA/MAA submissionExperience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus Associated topics: adult psychiatry, child psychiatry, clinical, consult, consultant, consulting, mhc, neuropsychiatry, psych, psychiatry

Medical Writing Program Director

Astellas
1229 Greenbriar Ln, Northbrook, IL 60065

Astellas is announcing a Medical Writing Program Director opportunity in Northbrook, IL.Purpose & Scope of Position:The individual acts as a Global Medical Writing Lead (GMWRL; medical writing representative on a global project team) in late-stage de... Read More

Astellas is announcing a Medical Writing Program Director opportunity in Northbrook, IL.Purpose & Scope of Position:The individual acts as a Global Medical Writing Lead (GMWRL; medical writing representative on a global project team) in late-stage development project teams. The individual provides leadership with respect to program documents and particularly will lead the writing activities for IND/IMPD and NDA/MAA dossier components, briefing documents, and responses to regulatory authorities and may act as a NDA/MAA expert across all programs. The individual analyzes proposed program, study and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual ensures a consistent pattern of successful completion of assigned program responsibilities through strategic problem-solving and the ability to marshal resources in a productive and efficient manner in order to produce high quality documents that meet Astellas corporate needs and global regulatory requirements. The individual provides intellectual leadership and contributes document knowledge and expertise to the global project team. The individual may be responsible for overall project document management within medical writing, ensuring effective, high quality and timely departmental output. The individual may lead a multidiscipline productivity or process initiative and drives efforts to ensure processes remain aligned with best practices and corporate needs.Essential Job Responsibilities:Acts as primary GMWRL for all assigned programs (generally late-stage development). Analyzes proposed program-related, study and other documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency; ensures alignment and consistency of information and messages across all individual documents.Defines, develops and implements GMWRL strategies and plans to accomplish global project objectives.As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.Collaborates with the programs global leads for development operations (GDOL), medical sciences (GML), and statistics (GSTATL) to ensure integrated and consistent Global Development Operations approaches and performance within the program.Collaborates with internal and external stakeholders.Provides timely and accurate updates to GDO leadership during project review to enable successful functional support of projects.Works closely with Line Management to ensure successful management of vendors.Assists the Functional Management Head or more senior management in ensuring a consistent pattern of successful completion of assigned departmental responsibilities.May be responsible for overall project document activities within Medical Writing, ensuring effective, high quality and timely departmental output; may act as a NDA/MAA expert across all programs.May lead a multidiscipline productivity or process initiative.Drives efforts to ensure processes remain aligned with best practices and corporate needs.Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 20% of time).Quantitative Dimensions:Contributes to the quality and performance of Contract Research Organization (CRO) and staff, impacting costs and program success.Directly or indirectly responsible for oversight of Medical Writing activities, through CRO alliances and performance management, with budgets up to $4-6M/year per program.Able to foster adherence to the departmental mission.Able to optimize the efficiency of the department and maintain positive and collaborative relationships with other departments, other members of project teams, and globally.Organizational context:Project track, program responsibility role.May lead a team of individuals including staff and CRO (CRO Global Medical Writing Lead [GMWRL]; Document.Working Group Facilitator [DWGF]; writer).Required Qualifications:BA/BS; 10+ years relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as writing professional in pharmaceutical industry, with 5 years experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry and having led the Medical Writing effort for at least 2 dossiers (NDA/MAA) or has evidence of an equivalent knowledge base. Preferred experience with advisory committee(s).Able to take a leading role in development of global standards and on global task forces.Demonstrated and substantial experience in leading the creation of IND/IMPD and NDA/MAA components, briefing documents, and responses to regulatory authorities.Activities require advanced information gathering and conceptual skills, recognition and analysis of potential problems, highly complex problem solving, resourcefulness and development of policies to prevent recurrence of problems.Strong communication and leadership skills; able to set strategy. Associated topics: administrative, administrative assistant, administrative support, assistant, asso, beverage, document, front desk, operation, support

Associate Director, Medical Writing

Ultragenyx Pharmaceutical
8082 Binford Rd, Novato, CA 94945

Why Join Us?To be a hero for our rare disease patientsUltragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases... Read More

Why Join Us?To be a hero for our rare disease patientsUltragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic 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 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 possibilitiesThe 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 documentsRequirements: 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 plusUltragenyx Pharmaceutical is an equal opportunity employer & prohibits 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. Associated topics: administrative, administrative staff, administrative support, assistant, associate, document, front office, food, operation, operational support

Director, Grant Writing & Administration

Virginia Government
12901 River Rd, Chesterfield, VA 23838

The Director, Grant Writing and Administration will seek out, coordinate and manage opportunities for grant funding that supports the mission of Virginia s Community Colleges (VCCS). The Director will serve as the chief grants officer for Academic Se... Read More

The Director, Grant Writing and Administration will seek out, coordinate and manage opportunities for grant funding that supports the mission of Virginia s Community Colleges (VCCS). The Director will serve as the chief grants officer for Academic Services and Research, the Foundation for Community Colleges Foundation (VFCC) and Workforce Development. The Director will provide technical expertise and support agency goals as identified in relevant strategic plans, including system initiatives, state-wide innovation, policy, multi-college programs and special projects. One overarching goal is to increase grant funding levels across targeted programs and operating units of the VCCS by securing maximum funding from foundations, corporations, and government sources. The Director will provide broad, overarching leadership and strategic oversight to support project directors in submitting grant applications, progress reports, grant budget development and revisions, requests for no cost extensions, and other documents requested by the funder. The Director is also responsible for protecting the VCCS by facilitating compliance with all federal regulations/state regulations and conditions or restrictions on expending foundation, private, and corporate funding.Minimum Qualifications A bachelor s degree required, or a combination of relevant experience and education that provides the required level of knowledge, skills and ability to successfully perform the functions of the job. Considerable experience of successfully writing and securing federal, state and private grants for non-profit and/or government agency. Considerable experience in successfully directing the oversight of grant seeking process: researching, coordinating, managing grant funding expenditures, reporting and meeting grant requirements. Strong federal grant technical writing skills and understanding of grant requirements, tracking, and reporting. Strong writing and oral communication skills, along with excellent interpersonal skills. Strong attention to detail, organizational and financial management skills. Ability to think and problem solve creatively. Ability to establish and maintain effective working relationships. Demonstrated success working in fast-paced, rapidly changing environment. Associated topics: fund, funding, grant, grant administration, grant administrator, grant management, proposal

Associate Director, Medical Writing

Alexion Pharmaceuticals
59 Tremont St, Boston, MA 02297

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 adisease area or set of clinical programs. Th... Read More

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 adisease 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 forclinical 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 anddevelopment regulatory submission documents, risk management plans, briefing books, regulatory response documents, pediatric investigational plans, and other IND/CTA or global regulatory submissiondocuments. Principal ResponsibilitiesAuthors 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, andprocesses. 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. QualificationsAt least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledgeExperience with global trials and regulatory submissions preferredExperience with partnering and managing CRO relationships a plusProven excellence in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projectsExperience desired in MW for rare diseases and capability to develop and implement innovative solutions for optimizing MW for rare disease studiesDemonstrated 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 skillsThorough knowledge of global regulatory requirements and ICH/GCP guidelinesAbility to establish excellent internal and external relationships, including alliance partners and vendorsExcellent project management skills, with emphasis on time management and timelines, and administrative skillsExcellent problem solving, organizational, and negotiating skillsTeam player who thrives in a team-based environmentWell-developed sense of ethics, responsibility, and respect for othersAgile learner with ability to work both collaboratively or independently, seeking advice as required.Results- and compliance-driven; sets standard of excellence for self and othersHigh level of flexibility and ability to innovate and adapt to changing conditionsEducationMS degree in life sciences or equivalent required; advanced degree in a relevant scientific/clinical/regulatory field preferred Associated topics: associate, beverage, chief operations officer, front desk, operation, operational assistant, operational support, operations director, staff, support

Senior Manager, Technical Writing

ServiceNow
3181 Orthello Way, Santa Clara, CA 95051

Description Senior Manager, Technical Writing Santa Clara, CA (preferred) or San Diego, CA This position reports to: Director of Information Experience ServiceNow is changing the way people work. With a service orientation toward the activities, task... Read More

Description Senior Manager, Technical Writing Santa Clara, CA (preferred) or San Diego, CA This position reports to: Director of Information Experience ServiceNow is changing the way people work. With a service orientation toward the activities, tasks, and processes that make up day-to-day work life, we help the modern enterprise operate faster and be more scalable than ever before. Were disruptive. We work hard but try not to take ourselves too seriously. We are highly adaptable and constantly evolving. We are passionate about our product, and we live for our customers. We have high expectations. A career at ServiceNow means challenging yourself to always be better. ServiceNow is loo ...

Associate Director, Medical Writing

Pacira Pharmaceuticals
35 E Shore Rd, Denville, NJ 07834

At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitme... Read More

At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for an Associate Director, Medical Writing.The primary purpose of this position is to set the strategy for authoring of clinical study related documents and regulatory submissions and to serve as the primary author of clinical study documents (study protocols, CSRs, etc) Responsible for establishing strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regard to document quality, and developing medical writing timelines, processes, and working standards.Working with Clinical development and Clinical Operation team, developing the clinical study synopsis and authoring clinical protocols, amendments, and CSRs.Working with Clinical, Regulatory or CMC Lead, determines document authoring resource needs, proactively identifies issues and solutions, and sets timelines and processes.Can independently serve as the lead writer for regulatory submission documents such as eCTD module 2, 3, and 4 summaries, meeting briefing documents, and other documents as needed.Writes clinical study and regulatory documents in compliance with company standard operating procedures (SOPs) and applicable health authority guidance and regulations.Ensures key messages are clear and consistent within and across documents.Contributes strategically and scientifically at the project team level.Contributes to formation of key messages in consultation with functional area experts.Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents.Manages vendors and external writers with regard to document quality; provides guidance to external writers on company standards and style and industry best practices for regulatory writing.Develops clinical and regulatory writing timelines, processes, and working standards; ensures company SOPs, templates, style guides, etc, are aligned with industry best practices.Contributes interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as needed.Provide management support for activities with outside vendors and business partners, as required.Working with Clinical and Regulatory Lead, prepares Clinical Development Strategy for clinical development projects.Depending on experience and need, may be assigned other clinical, regulatory or operational projects within the Clinical Department.The qualified individual will possess the following:Bachelor s Degree with a major in an analytical, data-oriented field of study from an accredited college or university is required; advanced degree is preferred.Minimum 5-7 years of relevant experience in Clinical Development, Clinical Writing, Medical Writing or a related function with pharmaceutical or biological products.Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable.Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with clinical, regulatory, medical and scientific terminology is necessary.Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment.Proficiency using Microsoft Word, Excel and PowerPoint.Excellent oral and written English communication skills.Ability to present scientific and technical information in a concise and clear manner.Experience with ex-US regulatory submissions is a plus Associated topics: administrative staff, assist, asso, associate, operation, operational assistant, operational support, records management, staff, support

Associate Director, Medical Writing

Ascent
8 Dorchester Rd, Woodcliff Lake, NJ 07677

Associate Director, Medical Writing - Neuroscience & General MedicineJob DescriptionThe Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for pro... Read More

Associate Director, Medical Writing - Neuroscience & General MedicineJob DescriptionThe Associate Director - Medical Writing will be the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors/vendors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.Responsibilities include but are not limited to:- Working on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors- Independently prepares and at times may direct, the writing of PCSs, protocols and protocol amendments- Independently prepares and at times may direct, all the writing of the CSRs including narratives- Works across functional areas to obtain all applicable source materials- Leads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports- Leads the medical writing activities for marketing application submission documents (eg, NDA, MAA)- Liaises with other functional areas and groups in the development of document standards and structure- Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design, and results across the program- Implements document quality controls, standards and best practicesJob Qualifications- BS required/MS preferred- Minimum of 8 years inducstry experience with 5 years medical writing experience in an industry setting, with specific experience with compounds in Neuroscience- Must have participated in or lead a major marketing application submission- Strong critical thinking and problem solving skills- Self-motivated with the ability to influence others- Ability to multitask on complex projects- Result driven with a mastery of time management and project planning- Able to work on site- Advanced working knowledge of MS project and MS Word- Experienced in the use of a documentum systemJob Requirements- Position is temp to perm- Exposure to and primary author of:o Regulatory marketing application NDA & MAAo Clinical study reports- 8 years in pharma with a minimum of 5 years in medical writing- Neurology experience required- 1 day/week work from home- Be able to work independentlyCompany Description:About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives. Associated topics: administrative coordinator, assistant, beverage, document, front desk, operation, operational assistant, operational support, staff, support

Tutor - Math, Reading, Writing

Tutoring Club
3402 Irish Shores Ln, Pearland, TX 77584

Tutor - Math, Reading, WritingTutoring Club is a full service tutoring company that provides tutoring is math, reading, writing, sciences, and SAT/ACT Prep. TThe primary responsibility of a Tutor is to engage the students in learning. The Tutor is a... Read More

Tutor - Math, Reading, WritingTutoring Club is a full service tutoring company that provides tutoring is math, reading, writing, sciences, and SAT/ACT Prep. TThe primary responsibility of a Tutor is to engage the students in learning. The Tutor is also a mentor to students; they will focus on helping the student understand the importance of tutoring by using their experience with college level material as a guide in helping the student understand the big picture. This position recommends other subjects that the student might need to enroll in to ensure that they are an all-around student and prepared for PSAT, SAT, ACT, etc. testing. They communicate recommendations and follow up with Academic Coordinator and/or Director/AD. Responsibilities The first priority is to help each student catch up, keep up, or jump ahead. Greet the student in a friendly, inviting way as the student arrives. Teach the lessons thoroughly enough that the student can competently complete their lessons confidently and independently. Celebrate student successes using positive words/phrases. Refocus students if they get off task. Challenge students to reach stretching, yet realistic academic goals. Reward performance through the use of TC tokens (10-20/session). Begin and end tutoring sessions on time. Keep the surrounding environment clean and ready for a new session. Obtain and return educational materials as necessary (such as books, calculators, rulers, etc). Follow all safety and health procedures as outlined in the Tutor Handbook. Perform Other Duties as assigned. Requirements Must have at least 2 years of college and currently enrolled in college. math, reading, writing, SAT/ACT Associated topics: agriculture, celestial mechanics, cell, college of mathematics, geoscience, materials chemistry, math, mathematics natural sciences, molecular, physical science

Middle School Writing Teacher

PLC Charter Schools
3120 S 99th Ave, Tolleson, AZ 85353

We are seeking for a Writing Teacher to join our team! You will educate students in one or more subjects at the middle school level in a charter school setting.Responsibilities:Manage and educate students in a classroom settingDevelop and implement e... Read More

We are seeking for a Writing Teacher to join our team! You will educate students in one or more subjects at the middle school level in a charter school setting.Responsibilities:Manage and educate students in a classroom settingDevelop and implement engaging lesson plansAdhere to established teaching curriculumMaintain positive relationships with students and parentsDocument and share student grades and evaluationsMaintain the health and safety of all studentsQualifications:Appropriate Arizona Teaching CertificateArizona IVP Fingerprint Clearance CardPrevious experience in teaching or other educational fieldsStrong classroom management skillsAbility to build rapport with studentsExcellent written and verbal communication skillsStrong leadership qualitiesJob Benefits:Full-time, 9 Month Position, Sick Leave Plan, Arizona State Retirement System, Medical, Dental, Vision, Short Term Disability, & Life Insurance.

Project Administrator (Technical Writing expertise)

Confidential
715 Gallatin St NW, Washington, DC 20011

Job Description - Project Administrator (Technical Writing expertise) (661298) Job Description Project Administrator (Technical Writing expertise) ( Job Number: 661298) Description : The NISC III program within the Leidos Civil group is seek... Read More

Job Description - Project Administrator (Technical Writing expertise) (661298) Job Description Project Administrator (Technical Writing expertise) ( Job Number: 661298) Description : The NISC III program within the Leidos Civil group is seeking a Project Admnistrator to collaborate with various IT Team members and related projects and programs for the Federal Aviation Administration (FAA In this role you will assist team members with day to day project activities and track activities, assist the project manager, Task order manager and other team members with documentation, status reports, and activity reports. Additionally, you will be will be respon ... Associated topics: content, document, documentation, documentation specialist, excel, file, ms office, technical writer, technical writing, writer

Promise Neighborhood Grant Writing Associate

AmeriCorps
883 Princess Ave, Camden, NJ 08101

Center For Family Services (CFS) is a large and exciting nonprofit human services agency based in Camden City, NJ. Center For Family Services has been a force for positive change since 1920, and offers more than 70 programs that support people in fin... Read More

Center For Family Services (CFS) is a large and exciting nonprofit human services agency based in Camden City, NJ. Center For Family Services has been a force for positive change since 1920, and offers more than 70 programs that support people in finding the vision, the hope, and the strength for a better life. Whether it is a child who is ready for preschool or a teen without a safe place to call home, we are dedicated to help. Our goal is to break the cycle of poverty, violence, trauma, and addiction and help people to overcome obstacles, to find comfort, and to build the foundation for a successful future. In order for us to continue to do this, we need your help. Due to recent growth, CFS seeks the support of a VISTA member to build the capacity of the Promise Neighborhood Initiative. The Promise Neighborhoods award brings funding to Camden over the next five years and will support the development and implementation of a pipeline of comprehensive cradle-to-college-to-career services to reach children at every age and stage of development. The Camden Promise Neighborhood Team, led by Center For Family Services and including community residents and community based organizations, is committed to providing children with access to great schools and strong systems of family and community support that will prepare them for college and career.In this position, you will write grants, develop funding partnerships, and support fundraising efforts to improve services at Promise Neighborhood. This is a great opportunity to learn about social services, public policy, community development, city government, and education. This position requires pre-service drug screening and criminal background checks. Terms : Permits working at another job during off hours , Permits attendance at school during off hours . Service Areas : Education , Neighborhood Revitalization , Community and Economic Development , Children/Youth , Health . Skills : General Skills , Community Organization , Fund raising/Grant Writing , Team Work , Writing/Editing , Social Services. Associated topics: fund, funding, grant, grant administration, grant administrator, grant management, proposal

Manager or Associate Director, Medical Writing

Medpace Holdings
3931 Dieckman Ln, Cincinnati, OH 45245

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Manager, Medical Writing to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumenta... Read More

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Manager, Medical Writing to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.ResponsibilitiesIntegral member of the team responsible for departmental hiring, training, management, and evaluation of Medical Writers and other support personnel;Supports the Medical Writing group in the development of clinical study protocols, clinical study reports, briefing documents, and IND, NDA, and MAA components across a variety of therapeutic areas;Acts as a primary writer and/or project manager for key documents or projects;Works with global Medical and Regulatory experts to understand, interpret, and apply the clinical considerations and regulatory strategies pertinent to document development;Works with Sponsors and internal departments to develop timelines for writing projects; andInvolved in determining and presenting the scope of work for bid proposals.QualificationsMaster s degree or PhD with at least 3 years of medical writing experience or Bachelor s degree with at least 5 years medical writing experience;Previous supervisory experience required;Strong computer skills, project management skills, and a high attention to detail;Strong communication skills (both written and oral);Strong analytical and problem-solving skills;Experience writing US and/or EU regulatory documents preferred;Scientific background preferred. Associated topics: deputy, direct, elementary vice principal, high school principal, middle school principal, principal, school principal, superintendent, supervise, vice principal

Manager, Medical Writing Transcatheter Heart Valve

Confidential
65 Parkwood, Irvine, CA 92620

Job Description - Manager, Medical Writing Transcatheter Heart Valve (013106) Job Description Manager, Medical Writing Transcatheter Heart Valve-013106 Description Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) gro... Read More

Job Description - Manager, Medical Writing Transcatheter Heart Valve (013106) Job Description Manager, Medical Writing Transcatheter Heart Valve-013106 Description Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease. As the Manager, Medical Writing you will work closely with clinical and regulatory professionals and other subject matter experts to create documents that effectively and clearly describe research results, product use and other medical information. You will also ensure that the documents and presentations compl ...