This role is expected to play a central role in BLA readiness, including oversight of the development, coordination, and execution of key BLA modules, and management of internal and external medical ...
This role is expected to play a central role in BLA readiness, including oversight of the development, coordination, and execution of key BLA modules, and management of internal and external medical ...
Litigation Attorney
Manhattan, NY · On-site
$90K - $100K/yr
BLA investigates and, when in the best interest of the city, settles pre-litigation claims for and against the City of New York. In resolving claims before litigation is commenced, BLA protects the ...
Litigation Attorney
Manhattan, NY · On-site
$90K - $100K/yr
BLA investigates and, when in the best interest of the city, settles pre-litigation claims for and against the City of New York. In resolving claims before litigation is commenced, BLA protects the ...
Litigation Attorney
Manhattan, NY · On-site
BLA investigates and, when in the best interest of the city, settles pre-litigation claims for and against the City of New York. In resolving claims before litigation is commenced, BLA protects the ...
Litigation Attorney
Manhattan, NY · On-site
BLA investigates and, when in the best interest of the city, settles pre-litigation claims for and against the City of New York. In resolving claims before litigation is commenced, BLA protects the ...
Director, Medical Writing
Sioux Falls, SD · Remote
$190K - $230K/yr
Biologics License Applications (BLA) * Supplemental BLAs (sBLA) * Integrated Summaries of Safety (ISS) * Integrated Summaries of Efficacy (ISE) * Marketing Authorization Applications (MAA) * Clinical ...
Quick apply
Director, Medical Writing
Sioux Falls, SD · Remote
$190K - $230K/yr
Biologics License Applications (BLA) * Supplemental BLAs (sBLA) * Integrated Summaries of Safety (ISS) * Integrated Summaries of Efficacy (ISE) * Marketing Authorization Applications (MAA) * Clinical ...
BLA investigates and, when in the best interest of the city, settles pre-litigation claims for and against the City of New York. In resolving claims before litigation is commenced, BLA protects the ...
BLA investigates and, when in the best interest of the city, settles pre-litigation claims for and against the City of New York. In resolving claims before litigation is commenced, BLA protects the ...
We are hiring "hackers", "rock stars", bla bla blah. What we are really hiring is a polyglot developer who gets shit done, takes the product/feature all the way to 100%, takes shortcuts when/where ...
We are hiring "hackers", "rock stars", bla bla blah. What we are really hiring is a polyglot developer who gets shit done, takes the product/feature all the way to 100%, takes shortcuts when/where ...
Developer
Portland, OR · On-site
We are hiring "hackers", "rock stars", bla bla blah. What we are really hiring is a polyglot developer who gets shit done, takes the product/feature all the way to 100%, takes shortcuts when/where ...
Developer
Portland, OR · On-site
We are hiring "hackers", "rock stars", bla bla blah. What we are really hiring is a polyglot developer who gets shit done, takes the product/feature all the way to 100%, takes shortcuts when/where ...
Director, Medical Writing
Sioux Falls, SD · On-site +1
$190K - $230K/yr
Biologics License Applications (BLA) * Supplemental BLAs (sBLA) * Integrated Summaries of Safety (ISS) * Integrated Summaries of Efficacy (ISE) * Marketing Authorization Applications (MAA) * Clinical ...
Director, Medical Writing
Sioux Falls, SD · On-site +1
$190K - $230K/yr
Biologics License Applications (BLA) * Supplemental BLAs (sBLA) * Integrated Summaries of Safety (ISS) * Integrated Summaries of Efficacy (ISE) * Marketing Authorization Applications (MAA) * Clinical ...
Director/Senior Director, Clinical Development
New York, NY · On-site
$227K - $348K/yr
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs). * Lead and/or mentor ...
Director/Senior Director, Clinical Development
New York, NY · On-site
$227K - $348K/yr
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs). * Lead and/or mentor ...
Author and review BLA submission documents * Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues ...
Author and review BLA submission documents * Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues ...
Director Regulatory Affairs - CMC
$160K - $211K/yr
Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned ...
Quick apply
Director Regulatory Affairs - CMC
$160K - $211K/yr
Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned ...
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs). * Lead and/or mentor ...
Quick apply
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs). * Lead and/or mentor ...
Additionally, there will be a strong focus on BLA-enabling activities including process characterization, PPQ Batches and BLA authoring and review. Your Role: * Provide technical leadership to the ...
Additionally, there will be a strong focus on BLA-enabling activities including process characterization, PPQ Batches and BLA authoring and review. Your Role: * Provide technical leadership to the ...
Director, Process Sciences, CMC
South San Francisco, CA · On-site
$220K - $235K/yr
Additionally, you will lead CMC BLA readiness by authoring dossiers and preparing health authority responses, while developing analytical control strategies for product life cycle management. Job ...
Director, Process Sciences, CMC
South San Francisco, CA · On-site
$220K - $235K/yr
Additionally, you will lead CMC BLA readiness by authoring dossiers and preparing health authority responses, while developing analytical control strategies for product life cycle management. Job ...
Director/Senior Director, Clinical Development
New York, NY · Hybrid
$227K - $348K/yr
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs). * Lead and/or mentor ...
Director/Senior Director, Clinical Development
New York, NY · Hybrid
$227K - $348K/yr
Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs). * Lead and/or mentor ...
Resident - BLA.A.FLO
Boston, MA · On-site
$82K - $115K/yr
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to ...
Resident - BLA.A.FLO
Boston, MA · On-site
$82K - $115K/yr
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to ...
Resident - BLA.A.FLO
Boston, MA · On-site
$82K - $115K/yr
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to ...
Resident - BLA.A.FLO
Boston, MA · On-site
$82K - $115K/yr
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to ...
Director, Process Sciences, CMC
$220K - $235K/yr
Additionally, you will lead CMC BLA readiness by authoring dossiers and preparing health authority responses, while developing analytical control strategies for product life cycle management. Job ...
Director, Process Sciences, CMC
$220K - $235K/yr
Additionally, you will lead CMC BLA readiness by authoring dossiers and preparing health authority responses, while developing analytical control strategies for product life cycle management. Job ...
A key role will be the regulatory authoring and creating a robust BLA submission. The role will focus on late stage product development of Aerofact and the biologic / device combination product ...
A key role will be the regulatory authoring and creating a robust BLA submission. The role will focus on late stage product development of Aerofact and the biologic / device combination product ...
Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management. * Author and review ...
Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management. * Author and review ...
Bla information
See salary details
$29.5K - $40.8K
11% of jobs
$50.5K is the 25th percentile. Wages below this are outliers.
$40.8K - $52K
17% of jobs
$52K - $63.3K
14% of jobs
The median wage is $74K / yr.
$63.3K - $74.6K
9% of jobs
$74.6K - $85.9K
8% of jobs
$85.9K - $97.1K
2% of jobs
$97.1K - $108.4K
1% of jobs
$114.7K is the 75th percentile. Wages above this are outliers.
$108.4K - $119.7K
23% of jobs
$119.7K - $131K
3% of jobs
$131K - $142.2K
5% of jobs
$142.2K - $153.5K
6% of jobs
$29.5K
$85.1K
$153.5K
How much do bla jobs pay per year?
What is the difference between Bla vs Data Analyst?
| Aspect | Bla | Data Analyst |
|---|---|---|
| Required Credentials | Typically requires a degree in a related field, sometimes certifications in specific tools | Bachelor's degree in statistics, computer science, or related field; certifications like Microsoft Excel or SQL are common |
| Work Environment | Often in office settings, collaborating with teams on projects | Office-based, working with data sets, reporting, and analysis tasks |
| Employer & Industry Usage | Used across various industries including tech, finance, healthcare | Commonly employed in finance, marketing, healthcare, and tech sectors |
| Common Search & Comparison Intent | People compare Bla to Data Analyst to understand roles, skills, and career paths |
The comparison between Bla and Data Analyst shows that both roles often require similar educational backgrounds and work environments. While Bla may have specific industry nuances, both roles are integral in data-driven decision-making across multiple sectors. Understanding these differences helps job seekers identify the right career path and required skills.
What are the key skills and qualifications needed to thrive as a Bla, and why are they important?
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Job description
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
GENERAL SUMMARY:
The Principal Medical Writer will support 4D-150, a gene therapy in late-stage development for retinal vascular diseases, including nAMD and DME, and associated BLA-enabling activities as well as clinical stage work within the lung program. This role is responsible for the planning, development, and delivery of high-quality clinical and regulatory documents across late-stage development, working closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, Quality, and external partners. This role is expected to play a central role in BLA readiness, including oversight of the development, coordination, and execution of key BLA modules, and management of internal and external medical writing resources to ensure timely, high-quality regulatory deliverables.
The ideal candidate brings strong late clinical-stage medical writing experience, demonstrated ability to manage complex timelines, and a deep understanding of regulatory expectations for global Phase 3 programs and BLA readiness.
MAJOR DUTIES & RESPONSIBILITIES:
- Provide oversight for the planning, development, and execution of BLA modules, working closely with Clinical Science, Regulatory Affairs, Data Science, and Quality to ensure alignment with submission strategy and timelines.
- Lead and coordinate external medical writers and vendors, including selection, scope definition, timeline management, content review, and quality oversight.
- Ensure consistency, scientific accuracy, and regulatory alignment across BLA components and supporting clinical documents.
- Serve as a key point of integration between internal subject matter experts and external writing resources to support efficient document development and review cycles.
- Author, review, and coordinate key clinical and regulatory documents for the 4D-150 Phase 3 program as well as for the early-phase lung program, including but not limited to protocols, protocol amendments, CSRs, IBs, DMC materials, briefing documents, and BLA-enabling content.
- Lead document planning and timeline management in collaboration with cross-functional teams to support aggressive development milestones.
- Ensure consistency, clarity, and scientific accuracy across clinical documents, aligning with regulatory standards and internal expectations for quality.
- Partner closely with Clinical Science, Biostatistics, and Clinical Operations to integrate data interpretations, safety narratives, and efficacy analyses.
- Manage document review cycles, address comments, and ensure timely resolution of feedback from internal stakeholders and external vendors.
- Maintain document version control and adherence to internal SOPs, templates, and quality standards.
- Contribute to continuous improvement of writing processes, tools, and templates to support scale-up of late-stage development activities.
- Other duties as assigned
QUALIFICATIONS:
Education
- Advanced degree in life sciences (MS, PhD, PharmD, MD) preferred; Bachelor's degree required.
Experience
- 5+ years of medical or clinical writing experience in biotech, pharmaceutical, or CRO settings.
- Direct experience supporting Phase 3 clinical trials required; direct experience supporting early clinical trials (Phase 1/2) preferred.
- Prior experience authoring or contributing to BLA-enabling documents strongly preferred.
Other Qualifications / Skills
- Strong understanding of ICH guidelines, FDA regulatory expectations, and clinical development processes.
- Demonstrated ability to manage multiple complex deliverables under tight timelines.
- Excellent written communication skills with attention to scientific detail and clarity.
- Proven ability to work effectively in a fast-paced, cross-functional environment.
- Experience in gene therapy is a plus.
- Experience with leveraging AI-enabled tools to aid in document authoring is a plus.
Travel
- Minimal; occasional travel (<10%) as needed.
Physical Requirements and Working Conditions:
Sedentary work involving extended periods of sitting, typing, and screen use. Repetitive hand and finger movements required. Virtual meetings may occur across time zones.
Base salary compensation range: $180,000 - 202,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
About 4D Molecular Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1 - 10 Employees
Headquarters location
Emeryville, CA, US
Year founded
2013