Senior Medical Writer- Clinical Focus

Veristat; United States; Remote; USD 116,000 - 128,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Senior Medical Writer with a clinical focus to lead regulatory writing projects across service lines and interface directly with clients. The role supports larger engagements as part of a delivery team, bringing expertise to help clients achieve their regulatory goals.

The Senior Medical Writer will contribute to document authorship, mentor junior writers, and drive quality across submissions for multiple products in a fast-paced environment. Remote-friendly within the US.

Qualifications

• Bachelor’s degree in a relevant field.
• 3+ years of regulatory writing experience or equivalent clinical documentation experience.
• Understand regulatory guidelines to lead teams and anticipate effects on health authority approvals.
• Experience in development of submission-level documents.
• Experience in Clinical Study Reports, Investigator Brochures, ISS and/or ISE protocols.

Responsibilities

• Lead smaller projects as the project lead and interface with the client.
• Support larger, more complex engagements as a member of a delivery team.
• Contribute to authorship of regulatory documents across service lines.
• Leverage expertise to help clients achieve regulatory goals.

Skills

MS Word

Document management

Lead project teams

Regulatory writing

Data synthesis

Education

Bachelor's degree

Tools

Microsoft Word

Job description

Job Description:

The Senior Medical Writer- Clinical Focus is a major contributor to document authorship for a variety of documents across different service lines. The Sr Medical Writer will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals.

Position specific overview

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture 70% remote workforce, 66% women-led teams

Learn more about our core values here!

What we offer

• The estimated hiring range for this role is $116K to $128K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
• Benefits vary by location and may include:
• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

What we look for

Education, Experience, Training, and Knowledge:

• Bachelor’s degree
• 3+ years of regulatory writing experience or equivalent experience with clinical related documentation
• Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
• Experience in the development of submission-level documents (does not require functioning as a document lead)
• Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE

Skills & Abilities:

• Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
• Strong understanding of the document creation process and of the drug development lifecycle
• Able to synthesize data across multiple data sources and documents to create summary reports
• Ability to conduct/lead a CRM and successfully lead a project team to consensus
• Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
• Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
• Ability to identify and institutionalize work practices that are most effective in order to ensureconsistency in performance

Automated Decision Making:

All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.