- 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
- 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
- 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
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Head of Medical Writing - Waltham, United States - Aerovate Therapeutics, Inc.
Description
Aerovate (AVTE) is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of people with rare cardiopulmonary disease. Our team has spent their careers in cardiopulmonary disease research, drug and aerosol development, commercialization and company building.
Our exceptional team of experts, industry veterans, and scientists is uniquely equipped to overcome the current challenges of treating these diseases and deliver novel therapeutics to make a meaningful difference for patients.
At Aerovate, we know the diversity of our team's backgrounds, talents, skills, and experiences not only makes us unique, but makes us stronger. Tenacious in our pursuit to make a difference and helping each other along the way, we know we can achieve better therapies to make a meaningful impact for patients.
Why Aerovate
Aerovate fosters an uplifting environment, collaborative peers, and a passion for learning that translates into making a difference for people with cardiopulmonary disease and their communities.
Aerovate's culture is one of inclusion, excellence, and respect in every way – for each other, the science, the community, and our mission. Both at work and in the clinic, we are committed to recruiting individuals that exemplify diversity in culture and life experience and are always striving to grow and improve. We recognize the urgency of our efforts, and we accept the challenge to do what's right for our patients and their communities.
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:
Competencies:
Qualifications
Aerovate Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws.
