Tech Writer II

Apex Life Sciences is seeking Tech Writers for a year long contract in Malborough, MA. Searching for a unique candidate who possesses graphics design and project management abilities and is able to excel in a highly regulated industry. This position reports through Research and Development and has a variety of dimensions to the position:

Key Responsibilities * Creates, reviews, and reproduces product text for medical product labeling. * Ensures all text for product labeling, Directions For Use, and equipment manuals meet all required legal, regulatory, clinical, marketing, packaging engineering, manufacturing (contract and internal) and R&D requirements through the use of corporate labeling guidelines and SOPs. * Design labeling materials according to specific parameters to meet the requirements of the corporate master brand. * Working knowledge of the following software: Adobe Acrobat, InDesign, Illustrator, Prisymedica, Easy Label and Microsoft Office Suite. * Establishes needs for translations as defined in the marketing/product specifications and manages the process for translation completions and reviews for project assigned. * Coordinates proofing of various Labeling materials (Directions for Use, Manuals, and Labels). * Coordinates reviews with all disciplines of various product labeling materials. * Manage multiple projects concurrently, while complying with good manufacturing practices (GMPs), regulatory, quality systems standards and labeling requirements.

Quality Systems Duties and Responsibilities: * Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. * 3 years graphics (labeling) experience/training, medical industry experience preferred. * High attention to detail. * Ability to manage several projects concurrently. * Ability to learn new skills and adapt to business needs. * Proficiency with Adobe Suite and Microsoft Office Suite. * Knowledgeable in GS1 barcode standards preferred. * Ability to work independently with minimal supervision. * Travel of up to 10% may be required * Candidates with previous medical device, pharmaceutical or biomedical product labeling experience is preferred.

Required education:

• Bachelor’s

Required experience:

• Adobe: 2 years