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We are searching for a polished, smart, passionate, caring, self-motivated Principal Medical Writer. The Principal Medical Writer is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio and is capable of working independently to achieve goals. The Medical Writer will be responsible for liaising with the appropriate team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion, reviewing documents related to the clinical trial protocols, CSR, etc. The Medical Writer will be responsible for ensuring adherence to department guidelines, templates, SOPs, and regulatory guidelines for all Medical Writing documents provided for their therapeutic area. The individual in this position will work independently writing CSRs, IBs and IB updates and Clinical Summaries for our vaccine portfolio.

Responsibilities (duties are not limited to the below and may evolve over time depending on business needs and individual expertise)

• Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
• Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
• Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Represents functional area in cross-functional team (either internally or externally).
• Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
• Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results.
• Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
• Provides leadership for medical writing processes, standards, and initiatives.
• Consult with the cross-functional team to ensure the maintenance of document quality and project timelines.
• Inform the leadership team, when required, of the status of projects and any issues that affect document quality and project budget.
• Manage the administrative requirements of the medical writing department.
• Prepare timelines of writing activities for assigned documents and validate dates with all impacted document production team members.
• Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, with editorial and quality control reviews
• Define document development strategy and resource needs for programs, including medical writing vendor engagement and oversight.
• Travel both domestically and internationally as business necessitates.

Education / Experience

• BS in Life Science or similar degree; Master level or Doctoral degree preferred.
• 5-10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
• Ideal candidate will have 8 years of experience working in biotechnology/pharmaceutical/CRO.
• Experience with infectious disease/vaccines a plus
• Prior experience with IND/CTA/NDA/BLA/MAA submissions and expertise in requirements
• Direct experience in the pharmaceutical/biotech industry with understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical communications
• Demonstrated project and people management experience

Knowledge / Skills / Abilities

• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Impeccable attention to detail and strong analytical and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to clearly present clinical data.
• Ability to work autonomously and multi-task in a fast-paced environment.
• Ability to act with integrity, professionalism, and maintain confidentiality.
• Flexibility/adaptability to working in a fast-paced and dynamic environment and to changing business needs and meet deadlines.
• Team player, with ability to work successfully across functions.
• Ability to influence decision making with or without authority, facilitate groups with diverse perspectives, across geographies, and bring teams to agreement
• Strong interpersonal skills that build productive relationships and influence others across the company.
• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
• Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
• Ability to give what it takes: demanding hours, with scheduling flexibility, with a start-up attitude of intense dedication.
• Humility and the belief you can make the world a better place is highly desired.

Values

• Be science-driven
• Communicate clearly, openly and respectfully
• Unite in teams and collaborations
• Learn and help others learn
• Act with integrity
• Get sh*t done

In compliance with the Equal Pay for Equal Work Act, the salary range for this role is $XX-$XX. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Vaxxinity also offers a variety of benefits including: health and disability insurance, 401(k) match, flexible spending accounts, EAP, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, experience level and location.

If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at (321) 777-3000

Vaxxinity is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Vaxxinity will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.