Job Description

PROJECT OVERVIEW:

We’re developing new technology and tools for patients and their caregivers that can integrate easily into daily life and help transform the detection, prevention, and management of disease.

OVERALL RESPONSIBILITIES:

As a Technical Communications Program Manager, you will drive the medical device design and development lifecycle deliverables such as medical labeling including instructions for use (IFUs) and other labeling materials to support company products and programs.

You will work closely with internal science, engineering, UX, clinical, quality, regulatory, and business development teams, as well as external vendors and partners, to develop design history files and labeling for our commercial and clinical devices.

TOP 3 DAILY RESPONSIBILITIES:

Work with cross-functional teams (including product, engineering, and regulatory, amongst others) to prepare design history file and user-focused documentation for company products in a regulated environment.

Define, generate, track, and manage required content to meet project deliverables.

Connect with project team members across product marketing/user experience, science/engineering, clinical/regulatory/quality, and supply chain/manufacturing to establish and deliver optimal product labeling and user instructions.

SKILL/EXPERIENCE/EDUCATION

MANDATORY

BA/BS degree in an English or Engineering field or equivalent practical experience.

3+ years of experience in technical writing in regulated industry

Excellent written and verbal communication, interpersonal, and negotiation skills.

Self-starter who continuously challenges the status quo.

Ability to drive a project to full completion, from project planning through customer fulfillment, user feedback and product end-of-life

Excellent attention to detail and ability to manage several workstreams in parallel

DESIRED

Master's degree in a relevant field (Communications, User Experience, Engineering, Business, etc.).

Proven ability to work in fast-paced, constantly evolving environments.

Strong communication and collaboration skills exhibited in operational setting.

Previously worked in regulated medical device industry and familiar with ISO 13485 and 21 CFR 820 regulations

Experience in design history file generation and product development design control processes (21 CFR 820.30).

Experience with products requiring localization/translation

Experience with the design and production of end-user-facing materials

Knowledge of document control systems (Agile, JAMA, eQMS systems)

Experience with Google Workspace (g Suite)

Skills in basic graphic layout (Adobe InDesign, Figma)

Experience with Usability or Human Factors Engineering

Some experience with Operations/Logistics would be helpful

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.