Technical Writer I in Marlborough, MA at Apex Life Sciences

Date Posted: 7/15/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a qualified Labeling Project Specialist to work with a prominent pharmaceutical company in Marlborough, MA. For immediate consideration, please send updated resumes to KMooney@apexlifesciences.com

We are eager to find a unique candidate with labeling and project management abilities/knowledge and someone able to excel in a highly regulated industry. This position reports through Research and Development (labeling) and has a variety of dimensions to the position.

Key Responsibilities

•Creates and gathers product text for medical product labeling from attending team meetings.

•Ensures that 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. 

•Redline and Design labeling materials according to specific parameters to meet the requirements of the corporate master brand. 

•Working knowledge of Microsoft Office software. Establishes needs for translations as defined in the marketing/product specifications and manages the process for translation completions and reviews for project assigned. 

•Coordinates/performs 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.

Qualifications

•Bachelors degree or equivalent work experience, preferably in business or technical writing.

•1-3 years 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. 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.