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Posted: Thursday, January 25, 2018 1:25 PM

Requisition ID 52480BR
Title Senior Medical Writer
Job Category Clinical Development
Job Description Purpose
The Senior Medical Writer is responsible for proficient medical writing support for medical, regulatory, publication, and other needs of Novo Nordisk Inc. (NNI) therapies and therapeutic areas. This position operates independently or with minimal direction and leverages his/her technical experience and understanding of the organization and its processes to guide the successful completion of key projects; this position may facilitate cross:departmental/cross:functional projects and work with external parties to ensure accurate exchange of information.
This position reports to a Medical Writing manager within Medical Writing and Education (MWE). The Senior Medical Writer is expected to develop and utilize a network of internal relationships with global and local cross:functional study and publication teams, administrators, management and personnel from other departments as needed. The Senior Medical Writer is also expected to network effectively with external resources (e.g., investigators and authors) and work closely with external vendors, stakeholders and agencies.
Essential Functions
General: Works independently with minimal direction; periodic review of progress and results is conducted by his/her own manager. Functions at a proficient level; demonstrates leadership qualities. May lead cross:functional project teams locally and/or globally. May act as a project leader with own manager oversight. Has the ability to identify and resolve problems related to Medical Writing projects, processes or tasks, with management support as needed. Exercises judgment within defined procedures and policies. Can be assigned to support more senior Medical Writers with the revision of relevant Standard Operating Procedures (SOPs) and procedures to ensure efficiency, smooth work flow, and implementation. May provide guidance to junior Medical Writers in the preparation and review of documents and other materials; may act as a mentor. Applies his/her experience to the quality assessment of documents. Maintains up:to:date knowledge and understanding of the laws, regulations, industry standards and company policies/procedures relevant to Medical Writing. Remains current with respect to the literature on Novo Nordisk therapeutic areas and competitor products. May have the capacity to leverage his/her knowledge of medical, regulatory and publication activities in assigned project areas to function effectively as a Project Medical Writer.
Publications: Interacts with local and global publication groups, journals, editors, authors, and others as necessary to ensure the successful completion of publication projects. Prepares and reviews manuscripts, meeting abstracts, scientific poster presentations, and other documents necessary for publication support. May be responsible for planning author meetings.
Regulatory Documents: Prepares and reviews clinical trial reports, summary documents, and other documents that support the regulatory needs of a project. May collaborate in the execution of regulatory submissions, in particular with respect to document preparation and review.
Physical Requirements
10:20 overnight travel required.
* An MS, MD or PhD in a Life Science or a PharmD required
* A minimum of 3 years of relevant experience required with a PhD, MD or PharmD, and 5 years of relevant experience with an MS
* Demonstrated proficiency and experience in the preparation of regulatory documents and/or publications
* General understanding of regulatory requirements and drug development processes
* Demonstrated proficiency in the use and understanding of computer software (e.g., word processing, graphics, document management)
Novo Nordisk is an Equal Opportunity Employer : M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
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• Location: Jersey Shore, plainsboro

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