Responsibilities:
- The Technical Writer/Analyst Medical Affairs, Business Process & Operations will support the file standardization for a new controlled document management system.
- S/He gathers documents, compiles information, and maintains records for creation of Medical Affairs internal documents.
- Reviews documents for accuracy and elevates issues to supervisor.
- This person will participate in change management activities relating to harmonizing Medical Operations processes across the Medical Device (MD) operating companies.
- This person will collaborate with Medical Affairs associates to help ensure that Medical Affairs’ documents align with the global cross-functional strategy.
- The candidate will be an experienced professional with a focus on creating forms, templates, data entry and organizing files in structured folders and SharePoint sites.
- This candidate shall also have experience creating training guides and Work Instructions.
- This person shall possess strong editorial skills including a good understanding of medical terminology and scientific publication bibliographic material.
- The successful candidate will contribute to dictionary of terms for understanding the hierarchy of products, disease states and specialties to build the smart search tools.
- This requires an understanding of medical terminology and evaluating synonymous keywords.
- This person shall support the Medical Affairs SharePoint team site creation and maintenance.
- This includes creating and assigning User Groups and Permissions, SharePoint Lists and Libraries.
- S/He will support medical operations cross-functionally within a matrix organization of medical device companies.
Qualifications:
- A Bachelor’s Degree with 6+ years of related medical/ healthcare industry experience is required.
- Experience with MS Office applications (Word, SharePoint Online/2013, Outlook, Excel) is required.
- Ability to synthesize and understand search terms to create dictionary lists.
- Demonstrated knowledge and experience with medical terminology and medical device products in regulatory compliance or healthcare compliance is preferred.
- Strong typing and MS Office365 and SharePoint skills are required.
- Previous experience managing short deadlines, working with colleagues in different time zones and countries is required. The ability to work with people in a matrixed organization is highly preferred.
- This position will be located in Somerville, NJ and will require 0% travel.
Kind Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - 732-662-7964
