Manager, R&D Document Control Management

Job Description

About This Role

The Manager, R&D Document Control Management will report to the Head of Document Control & Learning Management and will act as the Document Control point of contact for functions within the R&D organization. This role will be an expert in the document control process and technical writing skills.  This role will work closely with the business to create and update policies, standard operating procedures (SOPs), work instructions, job aids, and other types of controlled documents. They will be responsible for ensuring quality and compliance of the document control procedures.  This role will provide support for R&D Audits and Inspections.

This is a hybrid role with flexibility to work most of the week remotely.  The preferred location for this role will be Cambridge, MA, but the RTP, NC office location is also an option.

What You’ll Do

• Prepare and review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.
• Support Process Owners in the development and streamlining of content. 
• Work with subject matter experts and key functional department personnel to ensure timely development and accurate content of required documentation.
• Recommend revisions or changes in scope, formatting, and content as identified.
• Perform Quality Control reviews on process document content and formatting.
• Maintain and coordinate activities related to the document creation using the EDMS including document initiation, workflow support, revision, and retirement.

Who You Are

You are passionate about document management and driving results in a dynamic environment.  You are innovative and enjoy working through collaboration.  

Qualifications

Required Skills

• Bachelor's degree + 7 or more years of relevant work experience in Quality within the Pharmaceutical/Biotech industry is required; OR Associate’s degree + 9 or more years of relevant work experience in Quality within the Pharmaceutical/Biotech industry is required.
• Direct experience in technical writing, specifically SOPs, Work Instructions, Job Aids, etc. is required.  
• Direct experience in GXP compliant quality systems is required.
• Experienced in Microsoft office applications is required.
• Excellent written and verbal communication skills is required.

Additional Information

The base salary range for this position is $114,000 - $152,000. Base salary offered is determined though an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.