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.
- 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 firstname.lastname@example.org
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.