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Medical Writer

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Date: Aug 29, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  27619  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

Responsible for medical/clinical writing including authoring, reviewing, editing, and tracking of various technical Scientific and Clinical Affairs documents such as Health Hazard Risk Assessments, Clinical Evaluation Reports, Clinical Investigation Reports, Scientific Study Reports, Post-marketing Clinical Follow-up Plans, Investigator’s Brochures, Annual Reports to Regulatory Agencies, Publications/Manuscripts, and sections of documents for regulatory agency submission such as Investigational Device Exemptions (IDE)/premarket approval applications (PMAs). 

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Responsible for the document writing process collaborating with internal and external personnel for various Scientific and Clinical Affairs documents as noted above
  • Creates content: writes new content, makes changes/edits to existing content
  • Analyzes data from various sources; able to analyze, interpret, and critically evaluate clinical and nonclinical data.
  • Preparation of pre-clinical and clinical sections for regulatory documentation, such as IDE, PMA, IND, or CE-Mark Technical Dossier
  • Develops tools and templates.  Ensures template sections of documents remain current and consistent across documents/Business Units as applicable
  • Develops and maintains tools to track document status to ensure reporting requirements are met
  • Participates in selection and management of contract technical writers when warranted
  • Manages and tracks the authoring and submission of manuscripts and publications to various journals and conferences.  Develops posters, slides, and supporting materials as required
  • Maintains basic to advanced knowledge of the businesses’ products and the therapies in which they are used
  • Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards and applies this knowledge to the completion of all projects

 

OTHER DUTIES AND RESPONSIBILITIES

  • Develops and maintains effective working relationships with co-workers, internal customers, and external vendors.
  • Participates in department activities and contributes to a teamwork environment, operating according to the groups agreed upon expectations
  • Partners with subject matter experts to develop technical content that meets regulatory requirement, and to achieve specific and immediate business objectives.
  • Takes the initiative to report on project status; anticipates and alerts manager and internal customers of potential project difficulties.

 

 

 

 

 

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.  PhD in a scientific discipline preferred. 

 

 

Experience

  • Minimum 2 years technical writing experience in academic or the medical device/pharmaceutical industry.

 

Skills

  • Demonstrated ability to communicate effectively both verbally and in writing
  • Excellent organizational skills
  • Proven ability to establish working relationships with internal and external personnel
  • Ability to demonstrate professional level communication skills in writing/editing, graphic design, or project management as required
  • Knowledge of content management systems, XML, and desktop publishing systems
  • Positive and a proactive approach to identification and definition of problems, and with the development and implementation of solutions
  • Detail oriented and process driven
  • High level of adaptability, initiative, and willingness to take ownership and accept responsibility for actions and decisions
  • Must be able to collaborate and translate business objectives into tangible technical content for skill development at all levels
  • Highly disciplined with the ability to manage multiple projects simultaneously
  • Self-directed with ability to work independently
  • Demonstrated ability to use tact and diplomacy effectively while maintaining appropriate assertiveness and persistence
  • Knowledge and use of relevant PC software applications and skills to use them effectively

 

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

Target Pay Range:  $72,300.00 to $90,400.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  7.0%

 

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification. 


Nearest Major Market: Denver

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