Company
Biotech
PRINCIPALMEDICALWRITER
Neural analysis suggests this role is
optimal for Senior candidates.
“PRINCIPAL MEDICAL WRITER. Skills: Regulatory document authoring, Scientific publication writing, Project leadership. Author, review, and finalize regulatory documents. Develop scientific and medical communication deliverables”
What You'll Achieve.
Ensure successful delivery; Ensure client relationships; Ensure overall project satisfaction; Enhance efficiency and quality
Industry & Context.
Problem-solving abilities
What They're Looking For.
Must Have
PharmD, M. Pharm, PhD, MD, or postgraduate degree in Life Sciences, Medical Sciences, Pharmacy, or a related healthcare discipline, 10–11+ years of experience in medical writing, clinical research, or drug development environments, Minimum 5 years of hands-on experience authoring regulatory medical writing deliverables for global submissions, Understanding of clinical development processes, regulatory requirements, and submission standards across major health authorities, Experience preparing regulatory documents for agencies such as the FDA, EMA, and other international regulatory bodies, Advanced proficiency in Microsoft Office Suite, particularly Microsoft Word and document management functionalities, Demonstrated ability to manage multiple projects simultaneously while meeting strict deadlines, Proven leadership experience with the ability to mentor, train, and develop high-performing teams, Interpersonal skills and the ability to collaborate effectively with diverse stakeholders at all organizational levels, Adaptability, flexibility, and the ability to perform effectively in evolving and fast-paced environments, Sound judgment, decision-making capabilities, and a commitment to excellence and continuous improvement
Nice to Have
Scientific publication writing experience, including manuscripts, abstracts, and posters, is desirable
What You'll Do.
and finalize regulatory documents
Develop scientific and medical communication deliverables
Collaborate with statisticians
Support real-world evidence generation
Support scientific research initiatives
Ensure deliverables meet scientific
Adhere to applicable ICH guidelines
Adhere to industry best practices
Perform scientific reviews
Perform quality control assessments
Perform document validation activities
Lead client interactions
Lead project kick-off meetings
Lead cross-functional discussions
Manage communication across global time zones
Serve as a project lead for assigned accounts
Ensure successful project delivery
Ensure client relationships
Ensure overall project satisfaction
Drive innovation initiatives
Drive process optimization efforts
Drive automation opportunities
Enhance efficiency within medical writing
Enhance quality within medical writing
Design training programs
Deliver training programs
Strengthen technical expertise
Support professional development of team members
Support audit readiness activities
Contribute to SOP development
Contribute to work-instruction development
Ensure compliance with internal quality systems
Participate in business growth initiatives
Participate in operational improvements
Participate in strategic departmental activities
Provide leadership to medical writing team members
Provide coaching to medical writing team members
Provide performance management for medical writing team members
Provide mentoring for medical writing team members
Provide career development support for medical writing team
How You'll Work.
Team & Collaboration
Cross-functional discussions; Global time zones; Diverse stakeholders; All organizational levels
Communication Scope
Written communication; Verbal communication; Presentation skills; Scientific communication
Process & Methodology
Project lead, Manage multiple projects
Full Job Description
## Accountabilities Independently author, review, and finalize high-quality regulatory documents, including Clinical Study Reports (CSRs), Protocols, Investigator’s Brochures (IBs), Briefing Books, CTD modules, and other submission-related materials for global regulatory agencies. Develop scientific and medical communication deliverables such as manuscripts, abstracts, posters, slide decks, and other technical or scientific publications as required. Collaborate with statisticians, data analysts, and clinical teams to support real-world evidence generation and other scientific research initiatives. Ensure all deliverables meet scientific, regulatory, editorial, and quality standards while adhering to applicable ICH guidelines and industry best practices. Perform scientific reviews, quality control assessments, proofreading, and document validation activities to maintain high-quality outputs. Lead client interactions, project kick-off meetings, and cross-functional discussions while managing communication across global time zones. Serve as a project lead for assigned accounts, ensuring successful delivery, strong client relationships, and overall project satisfaction. Drive innovation initiatives, process optimization efforts, and automation opportunities to enhance efficiency and quality within the medical writing function. Design and deliver training programs that strengthen technical expertise and support the professional development of team members. Support audit readiness activities, contribute to SOP and work-instruction development, and ensure compliance with internal quality systems. Participate in business growth initiatives, operational improvements, and strategic departmental activities as needed. Provide leadership, coaching, performance management, mentoring, and career development support for medical writing team members. Requirements: PharmD, M.Pharm, PhD, MD, or postgraduate degree in Life Sciences, Medical Sciences, Pharmacy, or a related healthcare d
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