Sr. Director/Director, Technical Writing

Protego Biopharma, Inc.; San Diego (CA); Hybrid; USD 210,000 - 265,000; Full time

Benefits offered by this job

Incentive stock option plan

401k plan with employer contribution

Dental and Vision insurance

HSA, FSA, and supplemental insurance

Paid Time Off

Job summary

Protego Biopharma, Inc. is seeking a Director, Medical Writing to author, manage, and lead regulatory, clinical, and safety documents across drug development and lifecycle management.

You will guide strategy, ensure regulatory compliance, and drive timelines while partnering with cross-functional teams and external vendors to scale writing capacity.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Advanced degree (MS/PhD/PharmD) preferred but not required.
• 7+ years in medical writing, regulatory writing, or related field.
• Experience leading outsourced medical writing resources.

Responsibilities

• Author regulatory, clinical, and safety documents per FDA/EMA/ICH.
• Lead cross-functional teams to support global regulatory submissions.
• Manage document development timelines and review cycles.
• Summarize complex data into submission-ready content.
• Drive process improvements in medical writing standards and templates.
• Develop expertise in assigned therapeutic areas.
• Oversee external writers/CROs and ensure quality.

Skills

Regulatory writing

Leadership

Vendor management

Project management

Cross-functional

Documentation standards

Medical writing

Regulatory knowledge

MS Office

EDMS

Education

Bachelor's degree

Advanced degree preferred

Tools

CRO/vendor management

Job description

Protego Bio is a clinical-stage biotechnology company based in San Diego, California, focused on developing first-in-class small-molecule therapeutics that target protein misfolding diseases. By restoring protein stability and function through novel pharmacological chaperones, Protego aims to transform the treatment of rare and systemic diseases with significant unmet medical need.

Protego's lead program is being developed for AL amyloidosis and builds upon the clinically validated pharmacological chaperone approach pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, whose work led to the discovery and development of tafamidis for transthyretin amyloidosis (ATTR).

About the job

The Director, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents, including but not limited to protocols and protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), Common Technical Document (CTD) sections, briefing documents, and other submission-related documents. This position is the subject matter expert in regulatory writing and partners with cross-functional teams to provide strategic guidance and leadership ensuring documents are scientifically accurate, compliant with applicable regulatory requirements, and delivered according to project timelines. In addition, this position provides medical writing strategy and leadership across all phases of clinical development and post-marketing lifecycle management anticipating and leading process improvements and the advancement of medical writing standards and best practices.

Essential Functions and Responsibilities

• Author and prepare regulatory, clinical, and safety documents, ensuring scientific accuracy, consistency, and compliance with FDA, EMA, ICH, and other applicable regulatory requirements and company standards.
• Lead cross-functional collaborations with stakeholders review and finalize high-quality medical and regulatory documents that support clinical development through global regulatory submissions, from IND/CTA to NDA/MAA.
• Manage document development timelines, review cycles, and comment resolution activities to ensure timely delivery of project milestones.
• Interpret, analyze, and summarize complex clinical and scientific data into clear, accurate, and submission-ready content.
• Proactively contribute and lead development and continuous improvements of medical writing processes, capabilities, templates, style guides, and standard operating procedures through innovation and adoption of industry best practices and drive alignment across programs.
• Develop and maintain expertise in assigned therapeutic areas and products to support scientific and regulatory communication needs.
• Source, onboard, and oversee external medical writers and CRO/vendor partners to scale writing capacity during peak deliverable periods, ensuring quality, consistency, and on-time delivery.
• Provide writing support for manuscripts, abstracts, and posters for peer-reviewed journals and scientific congresses.
• Additional duties assigned as needed.

Required Education, Experience, Skills, And Abilities

• Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required. Equivalent combination of education and applicable job experience may be considered.
• Advanced degree (MS, PharmD, PhD) preferred but not required.
• 7+ years of relevant experience in medical writing, regulatory writing, document management, publishing, or medical writing operations within the biotechnology, pharmaceutical, CRO, or related healthcare industry environment.
• Demonstrated leadership experience authoring complex clinical and regulatory documents supporting drug development programs through global regulatory submissions (NDA/MAA).
• Experience procuring, onboarding, and overseeing outsourced medical writing resources (external writers/CROs) to meet peak deliverable demands.
• Exercise a high degree of independent judgment in determining approaches, priorities, and solutions for complex scientific and regulatory challenges.
• Expert scientific writing and editing skills, with exceptional attention to detail and commitment to quality, and the ability to communicate complex scientific information to both technical and non-technical audiences.
• Knowledge of drug development processes and applicable FDA, EMA, ICH, and other regulatory requirements and guidance related to clinical development and regulatory submissions.
• Proficiency with Microsoft Office applications, and electronic document management systems.
• Strong project management and organizational skills, with the ability to manage multiple and changing priorities and deliver high-quality work within established timelines in a dynamic development environment.
• Ability to collaborate effectively with cross-functional teams and stakeholders at all levels of the organization.
• Unless hired outside of the San Diego region, Protego headquarters, the incumbent will be expected to perform work in a hybrid model which is a minimum of 3 days onsite. Incumbents hired outside the San Diego region will operate in a remote work model as specified by the company.

Salary Range:

$210,000 - $265,000 a year

In addition to a competitive base salary, we offer stock options and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.

Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

Job Type:

Full-time

• Incentive stock option plan
• 401k plan with employer contribution
• Dental and Vision insurance
• HSA, FSA, and supplemental insurance plans
• Paid Time Off

Schedule:

Monday to Friday

Work Authorization

• United States (Required)

Additional Compensation

• Annual targeted bonus %

Work Location:

• Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 10% domestically and internationally for meetings or site visits as required.

Equal Opportunity Employer

Protego Biopharma, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.