Technical Writer

Highly Competitive Salary
  1. Permanent
  2. Medical Writing, Media & Publishing
  3. United States
Brooklyn Park, USA
Posting date: 08 Jul 2020
MC.ZH.30401

Proclinical is currently recruiting for a Technical Writer with a global pharmaceutical company located in Brooklyn Park, MN. As the Technical Writer, you will be responsible to author and produce process validation documents for submission to regulatory authorities.

Job Responsibilities:

  • Manage the preparation of a suite of regulatory documents.
  • Work with content owners and project teams to ensure that key information is clearly described.
  • Coordinate and complete cross functional team review of documents for editing and final signatures.
  • Create and track timelines for the production of assigned documents according to filing timelines.
  • Compile and enter data to be included in final reports and/or reviews to confirm accuracy.
  • Actively contribute to best practices and continuous improvement. Represent the group in functional and cross-functional initiatives/projects when required.
  • Compliant transfer of figures, data tables and other content into regulatory documents.
  • Provide exceptional customer service, technical support, and business services to customers and partners within Technical Operations group.

Skills and Requirements:

  • Bachelor's degree or equivalent required, Advanced degree in life sciences or other relevant field preferred.
  • 2+ years' relevant work experience in editing or writing.
  • Demonstrated clear, high-quality scientific writing style in the English language.
  • Experience in technical operations, regulatory affairs, and/or biotech CMC development functions preferred.
  • Experience of authoring and/or editing scientific reports and/or regulatory documentation.
  • Project management skills consistently achieves multiple tasks and goals on-time.
  • Strong interpersonal and verbal communication skills.
  • Influencing skills: can influence without authority.
  • Detail oriented with data presentation skills.
  • Ability to work effectively in a team environment, establishes strong collaborative relationships, resolves conflict by creating an atmosphere of openness and trust.
  • Self-starter. Must possess excellent business acumen, solid judgement, and able to work autonomously from established goals and strategic direction.
  • Able to handle multiple priorities, conflicts, and ambiguity.
  • Demonstrated ability to meet tight timelines and produce quality work.

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at (+1) 215-531-6914 or z.hines@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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