Job Description

Senior Manager, Medical Writing

Location: Boston, MA. (Seaport) - Hybrid (3 days onsite per week)

Base Salary: $170,000 - $200,000

Bonus: 18%

Equity: 55,000

Commuter Subsidy: $175/month (Parking)

Estimated Start Date: Late February.

Education: Bachelor’s + 7 years, Master’s + 5 years, or PhD + 2 years of experience in medical writing or a related field.

Top 3 Skills:

1. Experience with Pulmonary Fibrosis or LYT-100 is required
2. Strong knowledge of global regulatory guidelines (FDA, EMA, ICH)
3. Proven experience collaborating with external vendors and consultants

Role Overview

We are seeking a Senior Manager, Medical Writing to join the team supporting our pulmonary and oncology programs, specifically LYT-100 (pulmonary fibrosis) and LYT-200 (cancer). This role is pivotal in managing the writing and development of regulatory and clinical documents, as well as overseeing outsourced vendors. This is a hybrid position with 3 days per week onsite in our Boston office.

The Senior Manager will be the sole medical writer on the team and will report directly to Head of Clinical Development. The role offers an exciting opportunity to contribute to cutting-edge programs in the field of pulmonary fibrosis and oncology, with the flexibility to work alongside project teams and vendors to ensure timely, high-quality document production.

Key Responsibilities

• Document Development: Independently author and manage the development of clinical and regulatory documents, including protocols, clinical study reports, investigator brochures, safety reports, briefing documents, clinical summaries, publications, and regulatory submissions.
• Vendor Oversight: Initially, a significant portion of the role will involve managing external vendors for document preparation. Over time, smaller projects will be brought in-house, and you’ll oversee consultants and external writing resources.
• Collaboration: Work closely with cross-functional teams, including clinical, regulatory, and subject matter experts, to gather data, provide strategic input, and ensure that documents are clear, concise, and compliant with regulatory guidelines.
• Project Management: Develop and maintain timelines for document delivery, ensuring deadlines are met and quality standards are upheld. Manage competing priorities and communicate progress and issues to senior management.
• Regulatory Expertise: Ensure all documents comply with global regulatory guidance (e.g., ICH, FDA, EMA) and support the clinical development process at various stages.
• Process Improvement: Identify areas for process optimization and recommend improvements in document development or vendor management practices.

Basic Qualifications

Education: Bachelor’s degree in a life sciences discipline (advanced degrees preferred).

Experience:

• Bachelor’s + 7 years, Master’s + 5 years, or PhD + 2 years of experience in medical writing or a related field.
• Proven experience in writing and managing regulatory and clinical documents in the pharmaceutical or biotech industry.
• Experience with pulmonary fibrosis is a must; oncology experience is highly preferred.

Skills:

• Strong organizational, project management, and communication skills.
• Ability to work effectively under pressure and manage multiple priorities.
• Proficiency in global regulatory guidelines (FDA, EMA, ICH).
• Experience working with external vendors and consultants.
• Ability to interpret clinical data and summarize it in clear, concise text for regulatory submissions.
• Familiarity with publicly available databases (e.g., PubMed, FDA, EMA) for literature and information mining.

Additional Information

• This position is a hybrid role, requiring 3 days per week onsite in our Seaport, Boston office.
• The interview process will involve an initial meeting with the team followed by onsite interviews with the team.
• Parking: The company offers a $175/month commuter subsidy for parking. The attached garage costs approximately $87 per paycheck, with a nearby lot available for $110 per paycheck.

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