Medical Writer

Allen Spolden•New Milford, NJ

About The Position

The Medical Writer will primarily work on the development and delivery of high -quality documents such as Clinical protocols, protocol amendments, Investigator’s Brochures (IBs), non -clinical and clinical summaries together with integrated summaries (ISS and ISE), and other related clinical/regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications (NDAs) and Biologics License Applications (BLA) within agreed -upon timelines.

Requirements

Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment
Bachelor’s degree in life sciences or related disciplines; advance degree preferred (MD, PhD, PharmD, etc.)
Ability to work independently and collaboratively in a team environment consisting of internal and external contributors
Experience in managing multiple projects simultaneously
Excellent problem -solving skills with the ability to adapt to changing priorities and deadlines.
Excellent interpersonal skills and ability to work with cross -functional teams to meet business objectives.
Ability to initiate and generate with limited supervision medical, regulatory, and clinical documents within a reasonable timeframe
Ability to develop document templates for ongoing and future submissions depending upon the scope of the project.
Ability to pivot from one project to another and multitask
Ability to understand client objectives and provide feedback that supports projects and deliverables in multiple therapeutic areas
Ability to move efficiently in a dynamic environment
Excellent verbal and written communication and listening skills.
Highly proficient with Microsoft Office.
Effective time management
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
5+ years of clinical research experience
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven

Nice To Haves

Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus.
Bilingual in Mandarin and English is not required, but will be a plus

Responsibilities

Prepares, edits, and finalizes various documents, medical and technical from non -Clinical / pre -clinical to Phase IV studies.
Serves as medical writing representative on cross -functional study teams and provides guidance on document strategy and content, timelines, and resource needs
Manages the document development process from start to finish which may include generating multiple draft documents and formulating final approved versions, editing, reference retrieval, as well as managing other various processes are undergone (i.e., internal & external reviews, quality checks, audits, formatting, publishing).
Collaborates with cross -functional team to ensure results and statistical interpretations are accurately and clearly reflected in documents.
Participates in all necessary cross -functional document development meetings (i.e., kick -off meetings, comment resolution meetings) to ensure appropriate alignment from different stakeholders.
Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables.
Monitors regulatory, clinical/medical, and scientific findings and conclusions ensuring key messages are clear and consistent within and across documents.
Provides editorial or review support for other types of documents as requested.
Maintains ongoing familiarity of US and international regulations, requirements and guidance associated with the preparation and submissions of clinical regulatory documents and scientific publications
Proponent of Good Publications Practice Guidelines and understand the importance of adhering to the rules and regulations of External Scientific Professional Organizations and scientific journals.