Medical Writer jobs in Elizabeth, NJ
Recently Added Medical Writer jobs
Medical Writer
- Integrated Resources INC
-
Madison, NJ
FULL_TIME
- Company DescriptionA 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.This is Direct Hire Position with one of our ClientsJob DescriptionJob Description-• The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products.• This will be achieved by applying analytical skills, functional literacy and expertise in document preparation.• The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, REMS, key sections of the Investigator’s Brochure, the Annual Safety Report and regulatory briefing documents. • Individual will create and foster an environment of partnership with other members of product teams, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors. RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.• For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Author documents such as agency briefing documents, key sections of the Investigator’s Brochure, the Annual Safety Report and the core data sheet.• Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.• Develop and sustain constructive relationships within WSR, and with Development Operations.• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables).• Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management.• Serve as the point of contact (“go to” person) for one or more projects or products. • Organize and lead a MD matrix team of authors to deliver all MDL deliverables for each assigned project. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documentsTechnical Skill Requirements:• Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy.• Able to think creatively and to develop strategic plans that demonstrate sound judgment.• Exhibits sound project management and time management skills.• Able to interact effectively with all levels/roles of project team members.• Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.• Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise.• Is able to implement systems and processes and suggest process improvements.• Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines.• • Able to complete and turn around high quality outputs with only minimal guidance from managementQualifications• Scientific/medical academic background (e.g. PharmD/PhD or MSc/BSc with experience),or equivalent. • BS degree and 1 or more years of pharmaceutical experience preferred.• An advanced degree preferred and at least 3 years medical writing experience and /or experience in pharmaceutical development. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and non-scientific audiences. • Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance.• Able to clearly articulate scientific and clinical data in all written and verbal communication.• May include a track record of leadership abilities either as a direct supervisor or within a matrix settingAdditional Information
- 1 Month Ago
Medical Writer I, II or III
- Mitsubishi Tanabe Pharma America
-
Jersey, NJ
FULL_TIME
- Company DescriptionEntrepreneurialSpirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent co...
- 1 Month Ago
Researcher and Writer
- FitSeal LLC
-
Newark, NJ
FULL_TIME,CONTRACTOR
- The Biomaterials Research Lab (BRL) at Rutgers University is recognized as one of the most productive research laboratories in its field, boasting an impressive record of more than 50 scholarly public...
- Just Posted
Technical Writer
- Playbook
-
Jersey, NJ
FULL_TIME
- Company MissionAt Playbook we believe that everyone deserves the ability to get ahead with incredible sports & academic programs. Through our best in class technology and integrated platform services ...
- 5 Days Ago
Grant Writer
- The Salvation Army Eastern Territory
-
Union, NJ
FULL_TIME
- Overview The Grant Writer will work with the Director of Corporate and Foundation Giving and the Grants & Contracts Manager to secure funds from corporate, foundation, and government sources. The Gran...
- 1 Month Ago
Grant Writer
- Eightfold
-
Jersey, NJ
FULL_TIME
- Job Title: Grant WriterSalary Range: $50.00 - $55.00 per hourLocation: New Jersey (NJ)We are seeking a skilled and motivated Grant Writer to join our team and contribute to our mission in the public h...
- 1 Month Ago
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0 Medical Writer jobs found in Elizabeth, NJ area
Freelance Medical Writer
- Healthcare Consultancy Group
-
New York, NY
- Overview: Freelance Medical Writer Healthcare Consultancy Group (HCG) is seeking a freelance medical writer with strong ...
- 4/19/2024 12:00:00 AM
Senior Medical Writer (Protocols) - Remote
- MMS
-
New York, NY
- MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a p...
- 4/19/2024 12:00:00 AM
Principal Medical Writer
- MMS
-
Jersey City, NJ
- MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,...
- 4/18/2024 12:00:00 AM
Senior Medical Writer (Remote)
- MMS
-
Princeton, NJ
- MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a p...
- 4/18/2024 12:00:00 AM
Medical Writer I
- Allen Spolden
-
New Brunswick, NJ
- Job Description The Medical Writer will primarily work on the development and delivery of high-quality documents such as...
- 4/18/2024 12:00:00 AM
Medical Writer II
- Allen Spolden
-
New Brunswick, NJ
- Job Description The Medical Writer will primarily work on the development and delivery of high-quality documents such as...
- 4/18/2024 12:00:00 AM
Senior Medical Writer (Remote)
- MMS
-
New York, NY
- MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a p...
- 4/18/2024 12:00:00 AM
Senior Medical Writer (Remote)
- MMS
-
Princeton, NJ
- MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a p...
- 4/18/2024 12:00:00 AM
About Elizabeth, New Jersey
Elizabeth is both the largest city and the county seat of Union County, in New Jersey, United States.[21] As of the 2010 United States Census, the city had a total population of 124,969, retaining its ranking as New Jersey's fourth most populous city, behind Paterson.
[22] The population increased by 4,401 (3.7%) from the 120,568 counted in the 2000 Census, which had in turn increased by 10,566 (+9.6%) from the 110,002 counted in the 1990 Census.[23] For 2017, the Census Bureau's Population Estimates Program calculated a population of 130,215, an increase of 4.2% from the 2010 enumeration, ran...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Medical Writer jobs
$101,122 to $124,866
Elizabeth, New Jersey area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
What does a Medical Writer do?
Medical Writer in Kennesaw, GA
Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes.
April 23, 2023
Medical Writer in New York, NY
Produces the high-quality and on-time deliverables including, but not limited to, proposals, protocols, amendments, technical reports, manuscripts by editing text content, correcting spelling, grammar, abbreviation uses and ensuring the style consistency.
January 17, 2023
Medical Writer in San Diego, CA
Compile, write, and edit documents covering all phases of MEI’s clinical oncology/ hematology research, to include integrated summaries of data, risk/benefit analysis, etc.
March 12, 2023