Job Title: Lead MedicalWriter
Department: Medical Writing
JOB PURPOSE
Lead the medical writing team for accounts that require multiple writers to meet the content demands of customized medical communications initiatives, and/or lead multiple accounts.
JOB RESPONSIBILITIES
With minimal direction or supervision, responsible for assigned-client service: provide high-quality editorial oversight for all content including planning through review; maintain knowledge of project status (content development and review) to ensure editorial quality and successful completion of all client content projects; identify and develop new opportunities for projects (working with the account manager) and publications (working with the publications manager); interact with account manager, publications managers, and project managers to ensure adherence to timelines and deliverables.
RESPONSIBILITY/PERFORMANCE MEASUREMENT
Content Development-Work closely with assigned project management team to ensure high-quality editorial implementation of all assigned-client programs.
Effectively provides the information people need to know to do their jobs and to feel good about being a member of the assigned-client project team
Provides medicalwriters information and direction so that they can draft accurate, high-quality editorial content; serves as a resource for questions
Assesses potential projects to provide an estimate of writing time required for completion
Reviews content for the assigned-client projects and ensures that content reflects clients' objectives and preferences while staying on time and on budget
Cultivates and shares expertise in assigned therapeutic areas
Delegates tasks and decisions in a professional manner, sets clear objectives, and trusts people to perform
Shares responsibility and accountability for assigned-client projects
Consistently complies with Fishawack standard editorial procedures, including ethical standards
Communication-Effectively and proactively communicate with team members (editorial, project, client), authors/faculty, and vendors in areas related to project completion.
Ensures that information is communicated effectively
within
and
across
internal teams in a timely manner
Keeps project team and manager apprised of project(s) status (through weekly status meetings or routine email communications) and challenges encountered during the project (eg, changes in scope, delays in receiving comments) to ensure project completion on time and on budget
Proactively provides input to team members to enhance project outcomes
Prioritizes workload for medicalwriters on team
Offers to assist others in times of slow workloads and asks for assistance during times of heavy workloads
Business Development-Investigate, conceptualize, and strategize new medical communications projects and publications to support the assigned-client's needs and opportunities.
Supports account manager's efforts to identify and secure new business for assigned client in a timely manner
Understands scope of Fishawack's capabilities and how to tailor Fishawack's services to assigned-client's needs
Effectively identifies opportunities for content development for assigned client
Company Representation-Represent the company at client meetings (e.g, advisory boards, speaker-training meetings, business development initiatives) in a professional manner.
Serves as onsite editorial resource and content expert in a professional manner
Reviews and revises program content, as needed in an accurate and timely manner
Prepares speakers for their presentations in a professional manner
Anticipates additional onsite needs and proactively prepares for these needs
Proactively assists project team; acts as a collaborative team member
Is prepared to discuss top-line information pertaining to content of business development meetings; educates internal, non-medical team members about content-related issues
CORE COMPETENCIES FOR THIS POSITION
(The behaviors, skills and practices required to accomplish the objectives of this position and in the daily conduct of business.)
Written Communications-Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect
Timely Decision Making-Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision
Informing-Provides the information people need to know to do their jobs and to feel good about being a member of the project team; provides medicalwriters information and direction so that they can draft accurate, high-quality editorial content; is timely with information
Delegation-Clearly and comfortably delegates both routine and important tasks and decisions; broadly shares both responsibility and accountability; tends to trust people to perform; lets team members finish their own work
Composure-Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress
CORE COMPETENCIES FOR ALL FISHAWACK POSITIONS
Client Focus-Is dedicated to meeting
and exceeding
the expectations and requirements of clients; gets first-hand client information and uses it for improvements in services; acts with clients in mind; establishes and maintains effective relationships with clients and gains their trust and respect
Functional/Technical Skills-Has the functional and technical knowledge, skills, and creativity to do the job at an extremely high level of accomplishment
Ethics/Values/Integrity/Trust-Adheres to an appropriate and effective set of core values and beliefs during both good and bad times; acts in line with those values; acts in a direct and truthful way; can present the unvarnished truth in an appropriate and helpful manner; admits mistakes; doesn't misrepresent him/herself for personal gain
INTERACTIONS (EXTERNAL & INTERNAL DEPARTMENTS)
Clients
Authors/Thought Leaders/Experts
Vendors
Contract or Freelance Employees
All Employees
REQUIRED KNOWLEDGE, SKILLS, & ABILITIES
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and ability required.)
Education
Required: 4 year post secondary education, or equivalent experience; Bachelor's degree in the life sciences; PharmD or PhD highly preferred
Experience
5+ years of medical writing experience
5+ years of editorial process experience
2+ years of experience with assigned-client's projects
Special Knowledge/Skills
Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel
Proficiency in Internet and PubMed searches
Ability to work independently with minimal supervision, and as part of a team
$70k-104k yearly est. 60d+ ago
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Principal Medical Writer
Icon Clinical Research
Medical writer job in Blue Bell, PA
Principal MedicalWriter- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Principal MedicalWriter to join our diverse and dynamic team. As a Principal MedicalWriter at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards.
**What You Will Be Doing:**
- Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
- Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
- Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
- Mentoring and training junior medicalwriters, fostering a culture of excellence and professional growth.
- Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
**Your Profile:**
- Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
- Significant experience in medical writing, particularly in regulatory submissions and clinical documentation.
- Strong understanding of regulatory requirements and industry standards for clinical writing.
- Exceptional writing and editing skills, with a keen eye for detail and clarity.
- Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
- A commitment to maintaining high standards of quality and compliance in all medical writing activities.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (******************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (****************************************************** to apply
$69k-104k yearly est. 34d ago
Medical Writer
Systimmune, Inc.
Medical writer job in Princeton, NJ
The medicalwriter will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure.
Key Responsibilities:
* Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
* Act as a member of clinical trial teams
* Follow and track clinical documentation milestones
* Write/edit other strategic documents, as required
Required Qualifications:
* Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medicalwriter in the pharmaceutical industry PhD with at least 1 year experience as a medicalwriter in the pharmaceutical industry
* Excellent writing and effective communication skills
* Proven interpersonal, organizational and problem-solving skills in a matrix management environment.
* Knowledge of FDA and ICH guidelines
* Skilled in clinical data interpretation
* Proven experience writing/supporting major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)
Preferred Qualifications:
* Knowledge of drug development and regulatory requirements to guide document organization
* Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality
The hiring pay range for this position is $80,000 - $130,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$80k-130k yearly 30d ago
Medical Writer
Systimmune
Medical writer job in Princeton, NJ
The medicalwriter will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure.
Key Responsibilities:
Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
Act as a member of clinical trial teams
Follow and track clinical documentation milestones
Write/edit other strategic documents, as required
Required Qualifications:
Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medicalwriter in the pharmaceutical industry PhD with at least 1 year experience as a medicalwriter in the pharmaceutical industry
Excellent writing and effective communication skills
Proven interpersonal, organizational and problem-solving skills in a matrix management environment.
Knowledge of FDA and ICH guidelines
Skilled in clinical data interpretation
Proven experience writing/supporting major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)
Preferred Qualifications:
Knowledge of drug development and regulatory requirements to guide document organization
Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality
The hiring pay range for this position is $80,000 - $130,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs).
SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$80k-130k yearly Auto-Apply 29d ago
Medical Writer
Cs&S Staffing Solutions
Medical writer job in Princeton, NJ
Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx *You can apply through Indeed using mobile devices with this link.
Additional Information
$77k-116k yearly est. 1d ago
Associate Medical Writer
Bioclinica
Medical writer job in Princeton, NJ
Bioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network-and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations
Job Description
The MedicalWriter will be responsible for the creation and development of all study start-up documents such as the Site Manual and associated forms, as well any required Protocol Amendment Impact forms and Compliance Reports for the life of each study. The MedicalWriter is also expected to provide guidance and support to the Clinical Project Management Team, including the review of Project-Specific Work Instructions and attending document-related Sponsor calls.
Primary Responsibilities
Performs study start up responsibilities by:
Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels
Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries
Creating, modifying and finalizing Quality Control (QC) Summaries
Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation Reports
Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs
Creating, modifying and finalizing paper Source Documents based on ToOs
Creating, reviewing, modifying and finalizing MedComm Meeting Minutes
Attending internal and external meetings relating to the Site Manuals, IQA/PQA/QC Summaries, CRs/KPDs, Source Documents and any other MedComm-related study start-up documents
Running Scheduled Tasks for generating MedComm webpages
Maintaining MedComm document webpages
Checking MedComm webpages for errors
Performing Project Close-outs as they occur based on receipt of Study Closure forms
Reviewing and updating Charter Training Slides (CTS) and CTS quiz(zes) as needed
Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required
Manages the clinical study document development process by:
Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs
Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled
Providing guidance to assigned Project Teams and Project Team members
Providing language updates, as required, for all MedComm document templates as needed
Creating Final Effective documents
Secondary Responsibilities
Maintains Quality Service and Departmental Standards by:
Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
Updating department SOPs and Work Instructions as needed
Assisting in establishing and enforcing departmental standards
Contributes to team effort by:
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Participate in internal training activities
Helping others to achieve results
Performing other duties as assigned
Maintains Technical and Industry Knowledge by:
Staying up-to-date on response criteria publications posted by Medical Communications
Participating in Medical Writing Training activities, including creating/reviewing training modules
Participating in Clinical Project Management Training activities, including creating/reviewing training modules
Attending and participating in applicable company-sponsored training
Qualifications
Education:
Bachelor's Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred
Experience:
1+ years medical writing experience required
2+ years of experience in pharmaceutical/clinical/imaging research preferred
Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing
Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access)
Understanding and knowledge of medical and/or clinical trial terminology desired
Additional skill set:
Ability to work in a group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
Organization and time management skills for managing multiple projects concurrently
Additional Information
Working conditions:
Travel: 0-5%
Lifting: 0-10lbs
Other: Computer work for long periods of time
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic
$77k-116k yearly est. 1d ago
Medical Writer
CS&S Staffing Solutions
Medical writer job in Princeton, NJ
Please, review and apply for this position through the QCI system following the link below (Copy and Paste):
http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx
*You can apply through Indeed using mobile devices with this link.
Additional Information
$77k-116k yearly est. 60d+ ago
Medical Writer (Advanced Degree)
Octane Learning
Medical writer job in Princeton, NJ
THE COMPANY
Octane Learning is a professional learning and medical communications agency, working exclusively for pharmaceutical, biotech, medical device, and healthcare companies. We advise on learning strategies and create the right experiences, including online study, virtual, in-person and hybrid workshops, reference resources, sales/corporate training events, and more. We also work strategically with clients to create medical education for and outreach to healthcare professionals (HCPs) so they can make informed decisions in their practices.
As we are rapidly expanding and have an opportunity for a Scientific Writer/Content Specialist to join our team in Princeton, New Jersey.
THE LOCATION
This position requires work to be performed from our Princeton, NJ offices.
THE WORK
Reporting to the Director of Content and Strategy, you'll develop the content for: (1) several different styles of training, primarily interactive media such as eLearning, instructor-led courses/workshops, videos, and print resources; and (2) medical communications activities such as advisory boards, symposia, and speaker slide decks For these materials, within the constraints of our/clients' guidelines, you will:
Review client's goals and strategy
When appropriate, develop learning objectives, appropriate for the audience (role, level)
Create or select content (medical, legal, regulatory) that is accurate and flows logically
Apply general instructional design techniques, including (where appropriate) creating exercises and assessments, feedback, virtual meeting needs, ensuring materials are suitable for later translation, etc.
Obtain and incorporate input and insights from clients, subject matter experts (SMEs), key opinion leaders (KOLs), and other team members
Reference the content according to the established referencing standards
Provide additional strategic support, such as attending and developing executive summaries from advisory board meetings
Content spans life science company requirements, from medical to policy and procedures, compliance, etc. You'll be working primarily in Microsoft Word and Microsoft PowerPoint, often inside existing templates. You will work closely with internal team members to ensure successful project completion and delivery.
You'll also collaborate with your colleagues in the creative and development departments to help deliver the content in a way that is most impactful for the learner. This may involve a casual conversation or a brainstorming session to generate new ideas for presenting the information.
There will likely be opportunities for additional work in curriculum design, audit and gap analysis, content creation for marketing collateral, as well as learning strategy, as the workload presents, and your capacity/interest aligns.
As our work is collaborative, it will be necessary to work from our Princeton, NJ office, with some flexibility.
THE CANDIDATE
You have a Masters or Doctoral degree in a medical/scientific discipline.
You are proficient in PowerPoint and Word, with excellent writing and editorial skills - an English degree or minor is a plus.
You have the ability to convert scientific data into a clear, scientifically sound, well-structured 'story'.
You are well-organized, with strong attention to detail.
You have good presentation, communication, and interpersonal skills.
You should have the capacity to:
Work in a fast-paced environment, pivoting to the highest priority or client need
Bring creative ideas to the presentation and delivery of content
Faithfully execute written and verbal instructions and seek clarification, when needed
Work within established timelines and our clients' regulated environments
Attend project and client meetings, sometimes presenting your work
Consider or explore the needs and perspective of your audience
Speak your mind if you feel a project or process can be improved
Learn new things and cultivate your capabilities as the workload may dictate
THE FIT
We are more interested in finding the right talent and attitude than the exact match to a list of skills and qualifications. We're looking for someone that is excited and motivated to learn new things in creating learning/training/medical communications resources in scientific, compliance, and regulatory areas.
BENEFITS
Retirement Plan Matching
Medical Insurance
Dental Insurance
Vision Insurance
Disability Insurance
Paid Time Off
$77k-116k yearly est. Auto-Apply 60d+ ago
Medical Writers
Integrated Resources 4.5
Medical writer job in Spring House, PA
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Looking for MedicalWriters in Springhouse, PA
Client -Johnson and Johnson
Please share the updated resume at sweta(at)irionline.com
Additional Information
$72k-103k yearly est. 60d+ ago
Principal Medical Writer
Icon Plc 4.8
Medical writer job in Blue Bell, PA
Principal MedicalWriter- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Principal MedicalWriter to join our diverse and dynamic team. As a Principal MedicalWriter at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards.
What You Will Be Doing:
* Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
* Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
* Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
* Mentoring and training junior medicalwriters, fostering a culture of excellence and professional growth.
* Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
Your Profile:
* Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
* Significant experience in medical writing, particularly in regulatory submissions and clinical documentation.
* Strong understanding of regulatory requirements and industry standards for clinical writing.
* Exceptional writing and editing skills, with a keen eye for detail and clarity.
* Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
* A commitment to maintaining high standards of quality and compliance in all medical writing activities.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$67k-93k yearly est. 36d ago
Medical Writer
Artech Information System 4.8
Medical writer job in Pennington, NJ
Artech Information System , a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you.
Position: MedicalWriter
Location: Pennington, New Jersey-08534
Duration: 6 Months
Job Description:
Scientific Writer for Aggregate Reports:
Coordinate and author documents needed for regulatory submissions (eg, CSRs, CTD summary documents, aggregate safety reports, risk management plans), ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
Review and edit documents as required.
Considerable experience in Assignment on Cross Functional Teams would be an advantage.
Qualifications:
PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents. In addition, (i) demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals, (ii) good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, (iii) demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team, (iv) working knowledge of a document management system and basic knowledge of document publishing process, (v) analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator's Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. 6. Able to collaborate with project team to respond to health authority questions, requests, etc.7. Provide departmental management with adequate information to help assess resource needs.
Additional Information
All your information will be kept confidential according to EEO guidelines.
$79k-111k yearly est. 1d ago
Sr. Medical Writer
Taiho Oncology 4.4
Medical writer job in Princeton, NJ
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.
Remote
Employee Value Proposition:
At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to experience multiple facets of medical writing in a dynamic, collaborative, and cross functional environment.
Position Summary:
The Senior MedicalWriter, Medical Writing is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.
Performance Objectives:
Responsible for the development of high-quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including but not limited to Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments,.
Collaborate with Global Development Teams and Clinical Development to ensure alignment with program objectives.
Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
Owns and updates assigned Medical Writing SOPs, as necessary.
Education/Certification Requirements:
Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience.
Knowledge, Skills, and Abilities:
Minimum of 3 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
Previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
Working knowledge of Medical Writing requirements and document components.
Experience with templates and template development, and document management systems.
Excellent writing skills.
Good interpersonal skills that involve working well in a team environment and the ability to lead others.
Good organizational and planning skills; drive for results.
Ability to read, analyze and interpret scientific and technical information.
Effective analytical/problem solving skills.
Ability to write procedures.
Ability to follow instructions and synthesize information from multiple sources.
Strong PC skills including intermediate/advanced proficiency with MS Word, and basic proficiency with other MS Office products. Adept in learning additional software utilized at Taiho.
The pay range for this position at commencement of employment is expected to be between $116,450 - $137,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-Remote
$116.5k-137k yearly 6d ago
Bid/Proposal Writer
Easypark
Medical writer job in Moorestown, NJ
Moorestown
$59k-90k yearly est. 60d+ ago
Senior Science Writer
News Writer/Reporter, Cancer Discovery In Boston, Massachusetts
Medical writer job in Philadelphia, PA
The Senior Science Writer in the Communications and Public Relations Department will assist the director of science communications in translating scientific data and information related to cancer research into content that helps educate the public, policymakers, media and the health care industry about cancer research advances, the AACR's mission, and the importance of biomedical science and funding. In this capacity, the senior science writer will assist the director in implementing the AACR's communications and public relations plans that facilitate the accurate communication and reporting of the latest advances in cancer research from the AACR's meetings, journals, partnerships, and other scientific activities.
Responsibilities
The Senior Science Writer writes and edits content that helps promote awareness of AACR's scientific activities among the public, policymakers, the media, and others interested in cancer research. Responsibilities include:
Writing and editing scientific press releases, blog posts, and features about cancer research advances from the AACR's conferences, journal articles, and other scientific sources.
Developing scientific content for the AACR websites and social media platforms.
Staying abreast of the latest developments in various areas of cancer research, including basic and translational research, population research, and preclinical and clinical research.
Researching and gathering information on scientific topics of interest and participating in the SciComm Journal Club.
Assisting with the development of scientific video content for blogs and websites.
Assisting with writing scripts and letters for leadership, newsletter, Annual Report, and other content.
Collaborating with SciComm members and media relations staff to help identify important cancer research advances from AACR's journals, scientific conferences, programs, and other initiatives to communicate to the scientific/medical press, national press, policymakers, cancer research community, and the public.
Occasionally traveling to AACR conferences and other scientific programs to cover important scientific advances on the blog and websites as required.
Collaborating with other members of the AACR about science communications projects that support the AACR's mission and goals.
Qualifications
Ability to translate complex scientific concepts into lay language for press releases and other written materials, including science backgrounders, blog posts, development activities, and reports.
Ability to write compelling science content for lay audiences.
Skill to develop scientific video content, including interviews and editing.
Possesses outstanding editing skills and knowledge of AP style guide.
Excellent interpersonal skills, including being a team player capable of working effectively with AACR colleagues, membership, and leadership.
Good understanding of biomedical terminology.
Proficiency in social media.
EDUCATION AND TRAINING:
PhD in biomedical science; cancer research experience preferred.
Minimum of seven years of experience writing science content for a variety of target audiences, including scientists, media, and lay readers.
How to Apply:
Please upload your resume and cover letter (required).
Equal Opportunity Employer
$63k-101k yearly est. Auto-Apply 60d+ ago
Senior Technical Writer
Contact Government Services, LLC
Medical writer job in Philadelphia, PA
Job DescriptionSenior Technical WriterEmployment Type: Full-Time, ExperiencedDepartment: Technology Support CGS is seeking an experienced Senior Technical Writer to provide consultative, analytical, and documentation support for a large Federal agency initiative.
CGS brings motivated, highly skilled, and creative people together to solve the government's most dynamic problems with cutting-edge technology. To carry out our mission, we are seeking candidates who are excited to contribute to government innovation, appreciate collaboration, and can anticipate the needs of others. Here at CGS, we offer an environment in which our employees feel supported, and we encourage professional growth through various learning opportunities.
Skills and attributes for success:- Drafting and development of technical documentation related to a variety of projects in the IT space.- Work closely with project stakeholders to establish technical processes and procedures.- Document projects through the SDLC.- Provide status reports for multiple ongoing projects and related documentation efforts.- Assist with both user and admin level documentation.
Qualifications:- Excellent writing and Communication skills.- 5+ years experience with development of technical documentation.- 3+ years experience with development of user documentation.- Fluency with industry standard technical summary and reporting techniques including Agile project management methodology.- Ability to produce quality work independently or in a group setting.- Experience with MS Office Suite including Visio.- Willingness and ability to pass background check/security screening.
Ideally, you will also have:- Familiarity with Business Intelligence/Analysis applications.- Experience with Government software development policies and procedures.- Client facing communication experience.- Federal Agency issued security clearance.
Our Commitment:Contact Government Services (CGS) strives to simplify and enhance government bureaucracy through the optimization of human, technical, and financial resources. We combine cutting-edge technology with world-class personnel to deliver customized solutions that fit our client's specific needs. We are committed to solving the most challenging and dynamic problems.
For the past seven years, we've been growing our government-contracting portfolio, and along the way, we've created valuable partnerships by demonstrating a commitment to honesty, professionalism, and quality work.
Here at CGS we value honesty through hard work and self-awareness, professionalism in all we do, and to deliver the best quality to our consumers mending those relations for years to come.
We care about our employees. Therefore, we offer a comprehensive benefits package.- Health, Dental, and Vision- Life Insurance- 401k- Flexible Spending Account (Health, Dependent Care, and Commuter)- Paid Time Off and Observance of State/Federal Holidays
Contact Government Services, LLC is an Equal Opportunity Employer. Applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Join our team and become part of government innovation!
Explore additional job opportunities with CGS on our Job Board:**************************************** more information about CGS please visit: ************************** or contact: Email: *******************
#CJ
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$58k-78k yearly est. Easy Apply 29d ago
Business Development/Proposal Writer
BFW Group
Medical writer job in Philadelphia, PA
Job Description Business Development/Proposal Writer BFW Construction Project Managers **************** is a regional construction project management agency that works with building owners, institutions and construction management partners to build amazing structures that positively impact the community. BFW is seeking a Business Development Manager to join our team. In this role, you will be responsible for overseeing the RFP and RFQ processes, writing proposals, and developing new Client relationships. The ideal candidate should have a proven track record in business development and/or proposal writing within the construction/architecture/engineering or real estate industries.
Key Responsibilities:
Conduct research on RFPs and RFQs, and develop or leverage research platforms including AI.
Successfully respond to RFPs and RFQs, ensuring all requirements and deadlines are met.
Draft Successful responses to RFPs and RFQs.
Assist Operations Manager with Newsletter and managing social media posts.
Assist with maintaining BFWs mailing list of 15,000+ contacts.
Attend pre-proposal meetings and network with other Teams and potential bidders.
Actively participate in industry organizations such as WTS, CREW, ULI, BIA, GBCA, URA, PDC, BOMA, COAA, PA Housing Alliance, MD Affordable Housing Coalition and NAOIP.
Lead BFW into State and Federal Government contracting.
Qualifications:
Minimum of 3 years of experience in Business Development/Proposal Writing
Strong writing and communication skills.
Excellent time and project management skills.
Must adhere to our core values of Honesty, Integrity, Teamwork, and Commitment.
Benefits: Competitive salary, PTO, health care, 401K, life /disability insurance, education/training assistance
Contact: To apply please send resume to ***************. No phone calls please.
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$56k-86k yearly est. Easy Apply 27d ago
Associate Proposal Writer
Angeion Group 3.4
Medical writer job in Philadelphia, PA
Angeion Group is a fast-growing, international leader in progressive settlement administration-specializing in Class Action, Mass Tort, and Bankruptcy cases. We're on a mission to redefine the future of legal administration, and we're looking for passionate, purpose-driven individuals who are ready to make an impact.
At Angeion, you'll join a dynamic, global team united by a commitment to excellence. With colleagues across continents and a collaborative, forward-thinking culture, we offer more than just a job-we offer a career with purpose, growth, and community.
Whether you're just starting out or bringing deep expertise, you'll find opportunities to learn, lead, and shape the future with us.
Angeion Group is seeking a motivated Associate Proposal Writer to join our team. This position plays a key role in developing, organizing, and producing high-quality proposals and other client correspondences. You will collaborate directly with the Project Development Manager and Senior Management to create strategic, compliant, and compelling proposal materials that reflect our company's operational excellence and commitment to client success.
The ideal candidate is a proactive professional who thrives in a fast-paced environment, demonstrates exceptional attention to detail, and is eager to contribute to a high-performing, nationally recognized organization.
Key Responsibilities
Develop, write, and edit proposals including executive summaries, methodologies, budgets, and supporting materials.
Coordinate proposal activities, gather project information, obtain quotes from vendors/partners, and ensure consistency in messaging and compliance across submissions.
Research and respond to RFPs, amendments, legal documents, and class action settlement agreements.
Collect, organize, and manage data from internal and external databases, CRM systems, and vendors.
Ensure timely completion and submission of proposals by managing schedules, tracking progress, and coordinating input from contributors.
Collaborate with Business Development and Operations Teams to ensure seamless project handoffs and accurate cost estimates.
Maintain proposal templates, databases, and content libraries to support efficiency and quality in future submissions.
Continuously improve proposal processes and documentation practices to enhance accuracy and impact.
Communicate professionally with clients, vendors, and internal stakeholders across multiple departments and time zones.
Exhibit strong organizational skills and meticulous attention to detail while meeting multiple deadlines.
Perform additional duties and special projects as assigned by management.
Qualifications
Education & Experience
Bachelor's degree in a related field or discipline.
3-5 years of proven experience in proposal writing, project coordination, or a related function.
Demonstrated success in developing business proposals and cost estimates.
Skills & Competencies
Strong writing, editing, and research skills with the ability to translate technical information into clear, persuasive language.
Proven ability to manage multiple projects simultaneously in a deadline-driven environment.
Proficiency in MS Office 365 (Word, Excel, PowerPoint, Outlook, Teams, OneDrive).
Strong analytical, organizational, and problem-solving skills.
Excellent communication and collaboration skills with a professional demeanor.
Ability to adapt quickly to shifting priorities and respond effectively under pressure.
Familiarity with accounting principles and proposal management systems preferred.
Experience in financial, insurance, or legal industries is a plus.
Other Requirements
Must be authorized to work in the U.S. without company sponsorship, now or in the future.
Commitment to maintaining confidentiality and upholding company standards of professionalism.
Why You'll Love Working at Angeion
We care deeply about our people and offer a comprehensive benefits package, including:
Medical & Dental Insurance
Employer-Paid Vision
Employer-Paid Short & Long-Term Disability
Group Life Insurance
401(k) Offerings
Employee Assistance Program (EAP)
Time Off & Holidays:
120 Hours of Paid Time Off (PTO)
48 Hours of Sick Time (state dependent)
3 Floating Holidays
10 Paid Company Holidays:
Ready to make your mark in a company that values growth, innovation, and people?
Join us at Angeion Group-where your work truly matters.
$51k-71k yearly est. Auto-Apply 60d+ ago
Grant Writer and Outcomes Coordinator
Holy Redeemer Health System 3.6
Medical writer job in Philadelphia, PA
At Redeemer Health, we are dedicated to making a lasting impact in the lives of vulnerable populations. We invite you to join our diverse team and contribute to our mission of bringing help, hope, and healing through Redeemer Health entities such as Drueding Center (transitional housing and community services for homeless families), community group homes for individuals with intellectual and development disabilities, and food pantries. Our commitment to your professional growth is demonstrated through our wide variety of competitive benefits, educational assistance, and a unique onboarding program that ensures your long-term success by immersing you in our mission and time-honored service orientation. Your career with us is more than just a job - it's an opportunity where passion meets purpose, service meets excellence, and every role is a journey towards making a difference.
SUMMARY OF JOB
In keeping with Drueding Center's core principles of healing from trauma, restoring hope and rapidly ending homelessness this position is responsible for supporting a learning culture through the coordination of all data entry, analysis and reporting of program outcomes to aid to program development and delivery. Develops and implements tools to effectively measure program outcomes. Works collaboratively with the Leadership Team to insure compliance with all funders, licensing and accrediting bodies. The Quality Review Specialist also prepares all agency annual reports/updates. In addition, researches change in policy, program, resources and regulations that effect Drueding Center constituency. This position is also responsible for the research, development and writing of grant proposals and narrative reports to funders in collaboration with the Executive Director. In addition, assists with stewardship of donors, with special projects, public relations, website management, etc.
CONNECTING TO MISSION: Drueding Center continues the legacy of the Sisters of the Redeemer and embodies the mission of Redeemer Health, to care, comfort, and heal by providing trauma informed services to the most vulnerable among us, families who are or have experienced homelessness.
RECRUITMENT REQUIREMENTS
Bachelor's degree, Master's degree a plus
* Excellent verbal and written communication skills
* Proficient in Microsoft Office Suite
* Strong organizational skills and flexibility
* Valid Driver's License preferred
LICENSE AND REGULATORY REQUIREMENTS:
* Department of Human Services - child care licensing
* Keystone STARS
* NAEYC accreditation
* Creating PRESENCE certification
EQUAL OPPORTUNITY
Redeemer Health is an equal opportunity employer. We prohibit discrimination in employment due to race, color, gender, religion, creed, national origin, age, sex, sexual orientation, gender identity or expression, disability veteran status or any other protected classification required by law.
$47k-67k yearly est. Auto-Apply 49d ago
Grants Specialist, RACE - Jefferson Center City
Kennedy Medical Group, Practice, PC
Medical writer job in Philadelphia, PA
Job Details
The position of Research Administration Center of Excellence (RACE) Grants Specialist will be responsible for working with assigned departments as well as their Associate Director on post-award research activities while delivering excellent customer service. The position will perform support functions for TJU Principal Investigators (PIs), with a focus on ensuring that PIs have accurate and timely information to make decisions. The Grants Specialist will be provided an individualized opportunity to further their career path while receiving exposure to and training in more complex aspects of research administration. Portfolio assignments will be determined based on their experience, job level, and portfolio complexity (grant type/sponsors/PIs). Individuals within this role will communicate extensively and directly with faculty regarding their grant finances, progress reports, day-to-day needs, etc. The Grants Specialist will take on an increasingly complex research portfolio including but not limited to programmatic grants (Cooperative Agreements, Program Project Grants, and Training Grants).
Research is a vital component of the TJU's mission and support of research administration is a key component of success for RACE. The Grants Specialist positions within RACE are mid-level research administration staff positions requiring the incumbent to ensure proper stewardship of grants financial management. The Grants Specialist is a full-time position that will strive to meet the research needs of Principal Investigators in basic, applied, or clinical research. The Grants Specialist will report to the the Associate Director of their assigned team. The Grants Specialist models and fosters behavior that establishes a culture that values the staff/faculty partnership and is consistent with the values, goals, and objectives of the enterprise/department to create an atmosphere of trust, cooperation, accountability, empowerment, and dedication to the research mission of the enterprise.
Job Description
Examines awards for suitability of terms and conditions and reviews budgets with PI; coordinates establishment of project accounts for the grant and sub-awards (as applicable)
Working with Associate Director, administers grant by monitoring award and sub-awards for compliance, analyzing monthly financial reports, communicating with PI regarding financial progress and coordinating activities at the end of the budget period
Maintains accounting records for all awards within their assigned portfolio
Reconciles all assigned accounts against the General Ledger on a monthly basis
Coordinates personnel and purchasing activities with the PI and applicable TJU offices; review and act as a signatory (if designated by the PI) for budget summaries, budget adjustment forms, JVs, Travel Authorizations and Reimbursements, Invoices, Check Requests, Expense Reimbursements and Purchase Requisitions as necessary
Ensures payroll distribution is correct for faculty, graduate students, fellows and support staff on a bi-weekly basis and processes changes as needed
Meets with PIs at least monthly to provide updates on the financial status of their accounts
Acts as a liaison between PIs and ORA/SPAO to communicate and resolve any issues that arise concerning expenditures
Assists PIs with effort reports to ensure accuracy and timely submission
Assists PIs with budget development for progress reports
Assists with submission of progress reports, program reviews and other activities related to the grant
Working with ORA as appropriate, assists with providing just in time information or other agency requests such as budget revisions, compliance issues, etc.
Serves as a resource to department staff and faculty to ensure compliance with policy
Attends regular meetings, training sessions, and professional development workshops/seminars to keep current on policies and procedures relevant to position responsibilities, as requested and approved by the RACE Associate Director(s) (supervisor) or Director, Post-Award (RACE).
Education and Experience:
Associate's degree in General Studies, Business, Finance or Healthcare Administration, or related field required. Bachelor's degree preferred.
1.3+ years experience in research administration-related work.
Computer skills in a PC/Windows environment, including MS Word, Excel, and PowerPoint, demonstrated by application materials and previous experience.
Excellent written communication skills and attention to detail as demonstrated by application materials.
Work Shift
Workday Day (United States of America)
Worker Sub Type
Regular
Employee Entity
Thomas Jefferson University
Primary Location Address
1025 Walnut Street, Philadelphia, Pennsylvania, United States of America
Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.
Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.
Benefits
Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.
For more benefits information, please click here
$50k-73k yearly est. Auto-Apply 60d ago
Medical Writer
Artech Information System 4.8
Medical writer job in Pennington, NJ
Artech Information System, a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you.
Position: MedicalWriter
Location: Pennington, New Jersey-08534
Duration: 6 Months
Job Description:
Scientific Writer for Aggregate Reports:
Coordinate and author documents needed for regulatory submissions (eg, CSRs, CTD summary documents, aggregate safety reports, risk management plans), ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents.
Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
Review and edit documents as required.
Considerable experience in Assignment on Cross Functional Teams would be an advantage.
Qualifications:
PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents. In addition, (i) demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals, (ii) good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, (iii) demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team, (iv) working knowledge of a document management system and basic knowledge of document publishing process, (v) analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator's Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. 6. Able to collaborate with project team to respond to health authority questions, requests, etc.7. Provide departmental management with adequate information to help assess resource needs.
Additional Information
All your information will be kept confidential according to EEO guidelines.
How much does a medical writer earn in Mount Laurel, NJ?
The average medical writer in Mount Laurel, NJ earns between $65,000 and $139,000 annually. This compares to the national average medical writer range of $63,000 to $137,000.