Head of Medical Writing Nephrology

Biogen; South San Francisco (CA); On-site; USD 178,000 - 297,000; Full time

Job summary

A leading biotechnology company in South San Francisco is seeking a Head of Medical Writing for their nephrology unit. This role involves overseeing document development, managing a team, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in medical writing and a strong background in the biopharmaceutical industry. Join a team committed to innovation and patient impact.

Benefits

Comprehensive benefits package

Participation in incentive programs

Qualifications

• 12+ years' experience in the biopharmaceutical industry.
• 8+ years of direct medical writing experience.
• 3+ years of people management experience preferred.

Responsibilities

• Lead strategy discussions related to document development.
• Develop consistency in messaging and medical writing strategies.
• Mentor junior staff and foster their career development.

Skills

Communication

Regulatory Writing

Leadership

Education

Bachelor's Degree in Life Sciences

Advanced Degree

Job description

Company Description

Job Description

Biogen's West Coast Hub, based in South San Francisco, is focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We are seeking top talent to join us on this journey.

About This Role:

As the Head of Medical Writing (MW) - Nephrology, you will oversee complex development programs within Biogen's emerging nephrology / rare autoimmune disease portfolio. You will supervise the West Coast Hub Medical Writing team, coordinate with internal cross-functional teams and external partners, and contribute to the department's long-term growth and adherence to standard procedures.

What You'll Do:

1. Lead strategy discussions related to document development.
2. Develop and ensure consistency in messaging and medical writing strategies across documents within a therapeutic area or disease state.
3. Advance the medical writing function for the nephrology unit, including standard policies, procedures, timelines, and templates.
4. Direct medical writers in preparing clinical regulatory documents, including summaries for marketing applications and clinical trial documents.
5. Oversee vendor relationships and lead functional delivery of MW projects.
6. Mentor junior staff and foster their career development.
7. Partner with R&D to ensure timely, high-quality document completion.
8. Identify and lead process improvements within and outside the department.
9. Review statistical analysis plans and clinical data reports as needed.
10. Represent the department in R&D initiatives and process improvements.
11. Lead departmental initiatives and review documents for content and format.

Who You Are:

You possess exceptional communication skills, experience working in a matrix environment, and strong regulatory writing expertise. You are a knowledgeable leader in global clinical documentation requirements, a proven people manager, and a customer-focused professional with scientific acumen.

Qualifications:

Required Skills:

• Bachelor's Degree in Life Sciences or health discipline; advanced degree preferred.
• 12+ years' experience in the biopharmaceutical industry; relevant academic or research experience may be considered.
• 8+ years of direct medical writing experience.
• Therapeutic area expertise in clinical/regulatory documents.
• Experience managing a team of writers.
• 3+ years of people management experience preferred.

Additional Information:

The salary range is $178,000 - $297,000, based on experience and location. The role offers participation in incentive programs and a comprehensive benefits package.

Why Biogen?

We are committed to excellence, innovation, and inclusion. Our team offers opportunities for growth and making a meaningful impact in patients' lives. We value diversity and foster an inclusive environment where every employee can thrive.

Biogen is an equal opportunity employer, considering all qualified applicants without regard to protected characteristics. We are an E-Verify employer in the United States.