Aerovate Therapeutics
Waltham, Massachusetts, United States
(hybrid)
Member Company
23 days ago
Job Type
Full-Time
Job Duration
Indefinite
Min Experience
3-5 Years
Min Education
BA/BS/Undergraduate
Required Travel
0-10%
Work Setting
Non-Lab
Job Function
Medical Writer

Description

Duties and Responsibilities:

Position Summary: 

Reporting to the Head Development Operations the Head of Medical Writing is responsible for developing and implementing medical writing strategies, operational plans, and oversight and delivery of the medical writing function throughout the lifecycle of clinical development programs. This role will work collaboratively and strategically with our cross-functional teams and external partners to ensure that writing deliverables generated by Aerovate Therapeutics and third-party vendors are generated with the highest Good Clinical Practice (GCP), Good Documentation Practices (GDP), patient safety and quality standards, in accordance with regulatory requirements, established contractual agreements, budgets and timelines.

Responsibilities:       

·       Create and influence medical writing strategies and processes within and across functional areas

·       Provide guidance to colleagues regarding industry and medical writing best practices

·       Create writing guidelines based on familiarity with relevant document templates (e.g., NIH-FDA and Global Health Authorities clinical trial protocol templates, Structure and Content of CSRs)

·       Lead in-house and outsourced medical writing team to prepare clinical sections of regulatory documents (e.g., marketing applications, annual reports, briefing books,)

·       Coordinate and contribute to preparation of Clinical documents (i.e. Investigator’s Brochures, Clinical Study Reports)

·       Ensure and coordinate document quality checks for accuracy, collating reviewers’ comments, adjusting content of documents as required based on internal/external input, and preparation of the final version

·       Maintain and enhance therapeutic area working knowledge, including disease state and compound, for assigned projects and support literature searches required for document generation

·       Maintain and enhance working knowledge of regulatory guidelines and publication guidelines

·       Contribute to process improvement within and across functional areas

·       Work with teams to develop project specific metrics compliant with standard project metrics; influencing or negotiating change of timelines and content with other team members as needed

·       Coordinate activities related to preparation of scientific publications, including and not limited to, abstracts, posters, manuscripts and presentations as needed

Competencies:

·       Excellent written and verbal communication skills as well as proven ability to interact with multiple functional groups

·       Strong organizational skills and the ability to work in team-based environment

·       Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields

·       Good organizational, time management and interpersonal skills

·       Strong ‘Customer Focus’

·       Self-motivated with the ability to influence others

·       Result driven with the ability to demonstrate time management and project planning

·       Ability to analyze & interpret clinical data

 

 

 



Requirements

Qualifications

·       BS/BA in a science or industry-related discipline

·       Minimum of 10+ years’ experience in pharmaceutical R&D environment, including at least 3-5 years as a Medical Writer

·       Recognized for technical expertise in specific document development

·       Excellent, high-level, end-user computer skills (e.g., word processing, tables, graphics, spreadsheets, presentation and templates) and Microsoft software suite skills

·       Working knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirements

·       Thorough working knowledge/understanding of clinical trial design, methodology and statistical concepts; working knowledge of the IND/BLA/NDA process and ex-US marketing applications

·       Pulmonary Arterial Hypertension (PAH) experience a plus

 

 

 

Job ID: 72939243

Please refer to the company's website or job descriptions to learn more about them.

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