Urwah Admin

Biogen

<div><h2 class="jobSectionHeader">About This Role
</h2>Important note: This position is based in Riyadh, Saudi Arabia . The selected candidate must be located in Riyadh.
As the Rare Disease Business Unit Head for the GCC, you will play a critical leadership role in shaping and executing the rare disease strategy across the region. You will drive the successful launch and expansion of innovative therapies in areas such as SMA HD, ALS, and Friedreich&rsquo;s Ataxia - ensuring patients gain timely access to life-changing treatments.
You will lead the Rare Disease Business Unit across GCC countries, overseeing strategy, operations, and performance. Working in close partnership with the GCC Leadership Team and global stakeholders, you will build a high-performing organization, ensure cross-functional excellence, and deliver both patient impact and business results.
What You'll Do
<ul><li>Develop and execute the GCC rare disease commercial strategy at the local level, in close alignment with regional and global teams
</li><li>Establish and lead high-performing cross-functional in-country teams, ensuring full launch readiness across medical, value &amp; access, sales, and supply
</li><li>Drive the successful launch and expansion of therapies across SMA, including SMA HD, as well as ALS and FA
</li><li>Lead the development and execution of country-specific account plans to maximize patient access and organizational impact
</li><li>Collaborate with regional and global teams to adapt and localize marketing, medical, and value &amp; access strategies to local market needs
</li><li>Lead local segmentation and targeting processes, ensuring effective resource allocation and execution
</li><li>Define and oversee local sales targets, incentive structures, and performance review processes for commercial teams
</li><li>Own full P&amp;L responsibility for the Rare Disease Business Unit, delivering against financial and operational KPIs
</li><li>Build the necessary pathways and processes to accelerate approval, access, and reimbursement across GCC markets
</li><li>Ensure all launch activities are executed on time, on budget, and in compliance with internal governance and launch excellence frameworks
</li><li>Act as a key strategic partner to regional and global teams, providing insights on local market dynamics, opportunities, and challenges
</li><li>Establish strong governance and collaboration models with specialty business units to ensure alignment and effective use of shared resources
</li><li>Cultivate and maintain strong relationships with key stakeholders, including healthcare professionals, payers, professional organizations, and patient advocacy groups
</li><li>Partner with local and regional functional leaders to design and execute effective stakeholder engagement strategies
</li><li>Strengthen and maintain the organization&rsquo;s reputation within the rare disease community through trusted and compliant engagement
</li></ul>Who You Are
You are a strategic and entrepreneurial leader with a passion for making a meaningful impact in rare diseases. You thrive in complex, fast-evolving environments and bring a strong balance of vision and execution.
You are known for your ability to lead through influence, build high-performing teams, and navigate cross-functional and multicultural environments. You combine strong business acumen with deep empathy for patients, ensuring that every decision contributes to better outcomes.
You are collaborative, resilient, and driven, capable of translating strategy into action while inspiring those around you.
Required Skills
<ul><li>10+ years of experience in the pharmaceutical or biotech industry, with a significant number of years in a leadership role
</li><li>BSc/BA required (MBA preferred)
</li><li>Strong experience in rare diseases or specialty care strongly desired
</li><li>Proven track record of leading successful product launches across multiple markets, including pre-launch, launch readiness, and post-launch execution
</li><li>Demonstrated leadership experience building and managing high-performing cross-functional teams across multiple countries
</li><li>Proven ownership of full P&amp;L, including delivering financial targets and performance management
</li><li>Deep expertise in market access, pricing, reimbursement, and healthcare systems within the GCC region
</li><li>Strong understanding of Saudi Arabia, with relevant experience working in the market
</li><li>Strong experience developing and executing local commercial strategies, including account planning, segmentation, and targeting
</li><li>Experience defining sales targets, incentive structures, and performance management frameworks
</li><li>Proven ability to drive approval, access, and reimbursement pathways in complex environments
</li><li>Experience working in matrix organizations, collaborating with regional and global stakeholders
</li><li>Fluent in Arabic and English, with high proficiency in commercial IT systems (e.g., CRM platforms) 
</li></ul> 
Job Level: Management
<div><h2 class="jobSectionHeader"> 
Why Biogen?
</h2></div><div>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&amp;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.</div></div>

Business Unit Head Rare Disease - GCC

<div>This is a remote-based position, candidate must be located within the USA
<div><div><div><div><div><div><div><div><div>Must be available to start work daily by 9AM EST
</div></div></div></div></div></div></div></div></div>About This Role
The Medical Writing Redaction/Regulatory Response Specialist leads and executes redaction activities for clinical documents intended for public disclosure, ensuring compliance with global requirements and supporting Medical Writing in delivering high-quality redacted packages. The role also provides essential support for regulatory responses by organizing background materials, drafting and formatting response documents, coordinating cross-functional reviews, and ensuring alignment with internal standards and health authority expectations.
The Specialist reports to the Associate Director of Medical Writing Operations and is a is a core member of the Medical Writing Operations structure, contributing to both document delivery excellence and broader clinical submission readiness.
What You&rsquo;ll Do
<ul><li>Serve as the subject-matter expert on global redaction regulations and evolving health authority expectations
</li><li>Manage redaction of clinical documents in line with EMA Policy 0070, Health Canada PRCI, EU CTR, and other global requirements and oversee timely delivery of redaction workflows
</li><li>Maintain and update CCI redaction trackers across programs
</li><li>Assess internal and external technology solutions to improve redaction processes
</li><li>Support audits and inspections related to redaction activities
</li><li>Support Regulatory teams in preparing health authority responses (e.g., FDA, EMA, PMDA, Health Canada) by coordinating document collection, background materials, cross-functional input, and ensuring timely, compliant submissions
</li><li>Format, compile, and assemble response packages with consistency, clarity, and adherence to submission standards
</li><li>Assist Regulatory Leads with fact-checking and enhancing grammar, clarity, and flow of response documents
</li></ul>Who You Are
You are an insightful, customer-focused professional who collaborates effectively across diverse teams. You manage multiple priorities well, deliver high-quality work in dynamic environments, and bring strong organizational skills. You consistently demonstrate integrity, agility, and a positive approach in a fast-paced, compliant setting.
Required Skills
<ul><li>Minimum bachelor&rsquo;s degree, Life or Health Sciences preferred
</li><li>7+ years of experience in redaction operations, Medical Writing Operations, and/or regulatory affairs in the pharmaceutical industry
</li><li>Strong understanding of global redaction requirements (EU CTR, Policy 0070, PRCI, etc.)
</li><li>Exceptional attention to detail and strong written communication skills
</li><li>Ability to work under tight timelines with high quality and minimal supervision
</li><li>Strong organizational, timeline management, and cross-functional collaboration abilities
</li><li>Proficient with major Microsoft suite programs
</li><li>Experience in leading regulatory meetings
</li></ul>Preferred Skills
<ul><li>Project management experience
</li></ul>#LI-Remote 
 
Job Level: Management 
 
Additional Information
The base compensation range for this role is: $126,000.00-$176,000.00 
<div> 
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &amp; 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&rsquo; and their families physical, financial, emotional, and social well-being ; including, but not limited to:
<ul><li>Medical, Dental, Vision, &amp; Life insurances
</li><li>Fitness &amp; Wellness programs including a fitness reimbursement
</li><li>Short- and Long-Term Disability insurance
</li><li>A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
</li><li>Up to 12 company paid holidays + 3 paid days off for Personal Significance
</li><li>80 hours of sick time per calendar year
</li><li>Paid Maternity and Parental Leave benefit
</li><li>401(k) program participation with company matched contributions
</li><li>Employee stock purchase plan
</li><li>Tuition reimbursement of up to $10,000 per calendar year
</li><li>Employee Resource Groups participation
</li></ul></div><div>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&amp;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.</div></div>

Clinical Trials Redaction/Regulatory Response Specialist

Join Biogen and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Biogen

About Company

Business Unit Head Rare Disease - GCC

Clinical Trials Redaction/Regulatory Response Specialist