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Scientific Writer opportunities FT/Contract
Location: Lawrenceville, NJ - Telecommute
Salary: Negotiable
Visit website for more information.

Senior Scientific Writers (multiple openings)
Scientific Writers (multiple openings)
Contract Writers (multiple openings)

Primary Responsibilities:
Contract Position Description:
- Support scientists in preparation of regulatory documents (study reports, INDs, IBs)
- Participate in relevant filing teams and ensure effective planning and management of timelines for all components of assigned documents; work proactively with scientist and Project Manager to ensure timelines are met.
-Comply with internal and external processes and guidelines while managing document review processes
-Resolve issues, errors, or inconsistencies to ensure high quality documents.
-Create structures and manage documents in our document management system
-Ensure compliance of documents with submission and publication standards
- Experience with a document management system.
Under supervision of a senior member of the department, write and edit clinical documents needed for regulatory purposes (eg, protocols, study reports, Investigator Brochures) for submission within established timelines to support the goals of the R&D development team.

Senior Scientific Writer (Full time)
•Integrate a large quantity of information to create concise, clear, consistent, readable documents.
•Ensure that assigned documents accurately reflect the data provided and are consistent, clear, adhere to guidelines, and conform to project-specific standards.
•Understand statistical results and use this knowledge in preparing documents.
•Gather background information, data, previous samples of similar documents, etc., to prepare for writing task.
•With appropriate guidance, define document content.
•In accordance with the SOPs and related work practice documents, manage the processes for document preparation within established timelines.
•Follow the Core Template, other Model Documents, departmental guidelines for specific documents, and ICH and health authority regulations in the preparation of documents.
•Together with the Dossier Management Group, coordinate the distribution, review, and approval process for assigned documents.
•Work effectively with the Document Publishers to ensure that all appendix materials are available at the required times.
•Exhibit reasonable mastery of the electronic environment in which documents are produced, e.g., Microsoft Word, PowerPoint.
•Use CARA (Constellation Authoring, Review and Approval system) according to company policy as the docbase for all regulatory documents.
•Follow applicable Best Practices to maintain integrity of electronic and paper files and version control.
•As assigned, perform quality review of 1) documents written by other writers and 2) materials submitted by other functions for incorporation into documents to ensure accuracy, consistency, clarity, and appropriate adherence to guidelines.
•Learn to prioritize assignments with guidance.
•Develop familiarity with the drug development process, particularly a thorough knowledge of the structure of essential clinical documents.
•Develop an understanding of experimental design including selection of treatments, randomization of treatments, and specification of measures of effect
•Develop ability to coordinate comments and resolve issues diplomatically within the teams.
•Provide administrative information to maintain the document tracking system.
•Work effectively in multi-functional teams.
•Maintain confidentiality of sensitive information.

Education Requirements:

- BS with a minimum of 5 years experience in pharmaceutical regulatory documentation, or equivalent


- Demonstrated skills in managing the production of scientific documents

- Attention to detail and quality

- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

- Ability to multi-task across functional and organizational groups.

- Sense of urgency, flexibility and ability to prioritize or shift priorities to meet aggressive and changing deadlines.

Application Instructions:
Contact Stanley Howell at stanley.howell@bms.com, Karen Moretti at Karen.Moretti@bms.com or Darryl L'Heureux at Darryl.LHeureux@bms.com

Website: Visit website for more information and/or to apply.

About the Organization:
Bristol-Myers Squibb

Contact Information:
Darryl L'Heureux and Stanley Howell | | stanley.howell@bms.com and darryl.l'heureux@bms.com

Listing: ID# 38 - 9/7/2017 - 10/22/2017
Posted: 9/7/2017