This is an on-site W-2 contract.

Responsibilities

Responsible for providing scientific publications to the clinical teams and effective implementation of the clinical writing process

Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area

Interfaces with external groups (eg, PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications

Implements all activities related to the preparation of scientific publications (eg. Abstracts, posters/oral presentations, manuscripts)

Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing projects

Serves as a department representative on project teams

Communicates deliverables needed, writing process, and timelines to team members

Understands, assimilates, and interprets sources of information with appropriate guidance/direction from product teams and/or authors. Ensure required documentation is obtained

Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols

Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements

Confirms completeness of information to be presented. Challenges conclusions when necessary

Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs

Arranges and conducts review meetings with the team

Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate

Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications

Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (eg. eDocs, eCTD, journal/congress databases)

Serves as medical writing lead on scientific publications

Works closely with the Publications team(s) on document strategies

Learns and applies knowledge of therapeutic area and product to scientific publishing projects. 

Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience.

Requirements

American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical

3 yrs relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D

3 years experience in experimental design and clinical/preclinical data interpretation preferred

Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions

Knowledge and experience with Common Technical Document content templates

Working knowledge of current electronic document management systems and information technology

Excellent written and oral communication skills

Ability to assimilate and interpret scientific content and translate information for appropriate audience

Superior attention to detail

Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy

Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment

Experience in working with collaborative, cross-functional teams, including project management experience

This is an on-site W-2 contract.

Responsibilities

Provides medical perspective, gathers/analyses data, writing activities and quality checking for scheduled regulatory periodic safety reports (PSURs, Addendums, Bridging Reports and PADERs) for marketed products

Executes processes within the quality system for generating reports and analysis/presentation of data under the direction of a project manager or as the project manager

Participates in data collection, database searching, analysis, medical writing/editing, report preparation, case correction, and qualitative/quantitative review

Interacts with a cross-functional safety team of physicians, health care professionals, medical writers and regulatory affairs professionals to produce high quality and medically accurate regulatory documents. Prepares technical documents to support both domestic and international regulatory submissions.

Incorporates text, graphs, charts, tables and statistical analysis

Proofreads, circulates, edits, assembles, inspects and duplicates product submissions

This is an on-site W-2 contract.

Responsibilities

Assist Project Manager(s), Clinical Trial Registration & Results Disclosure (CTR/RD) with the oversight and project management of the planning and execution of clinical drug trial results disclosure postings per the applicable regulatory requirements.

Specifically, responsible for assisting in ensuring that all applicable trials have results disclosed on ClinicalTrials.gov with accurate and complete data

May prepare technical documents to support both domestic and international regulatory submissions

Prepares technical documents to support both domestic and international regulatory submissions.

Incorporates text, graphs, charts, tables and statistical analysis.

Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.

Requires a Clinical Background

Bachelor's degree or equivalent relevant experience is required preferably in nursing, pharmacy or scientific field.

Clinical research experience or in a related area such as quality or regulatory