Medical Writing Process Manager

Company: Biogen
Location: Cambridge
Posted on: January 13, 2022

Job Description:

Job Description

About This Role:

As the Medical Writing Process Manager you will be responsible for overseeing the development and revision of Standard Operating Procedures for processes that fall under the remit of the Medical Writing Department. These include SOPs and Job Aids for the development of clinical protocols, clinical study reports, and investigators brochures. You will also work with the GSRS quality group and subject matter experts to support internal process audits as well as inspections that may be conducted by global health authorities. As the Medical Writing Process Manager you will work closely with the Medical Writing Leadership Team to prepare and deliver training to both FTEs and contract medical writers on processes and systems use. You will also work with the Medical Writing Leadership team to evaluate and streamline organizational processes leveraging existing and new technologies and assist with managing and tracking medical writing projects though the medical writing document database. As the Medical Writing Process Manager you will also work closely with Document Quality on the document QC processes that are in place and serve as an ad hoc quality reviewer as needed.

What You'll Do

• Lead the revision and update process for Medical Writing SOPs and job aids.
• Develop and deliver training (including DQ review) to incoming FTEs and contractors.
• Support audit and inspection activities in partnership with medical writing SME's.
• Perform ad hoc document quality reviews.
• Support tracking of medical writing deliverables and vendor resourcing.
• Evaluate and implement new technology to improve department infrastructure and processes.
  Who You Are
  
  In addition to having excellent written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams. You have excellent organizational abilities and function well on cross-functional teams. You are highly proficient and experienced with most clinical document types and the processes used to author those documents. You have expertise in process development and preparation of associated job aids and process maps. You have a strong understanding of internal and external guidelines and regulations related to document preparation and program support.
  
  Qualifications
  
  Required Skills
  
  • A Bachelor's Degree (Life Sciences or health discipline preferred).
  • 3-5 years biopharmaceutical industry experience and familiarity with regulatory medical writing processes.
  • Advanced degree, academic research, and/or transferrable skills may be considered in lieu of industry experience.
    Additional Information
    
    Why Biogen?
    
    Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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