Director, Global Medical Writing

Regulatory Toolkit; United States; Remote; USD 175,000 - 215,000; Full time

Benefits offered by this job

Annual bonus

Benefits package

Parental leave

Growth opportunities

Job summary

Deciphera is seeking an experienced Director, Global Medical Writing to lead the writer program across clinical programs and regulatory submissions. The role requires independent writing and management of study documents such as protocols, master protocols, Investigator's brochures, and clinical study reports.

Reporting to the Senior Director, Global Medical Writing, you will guide cross-functional teams, maintain up-to-date industry knowledge, mentor 1–2 writers, and drive process improvements

Qualifications

• Advanced degree (MS or Ph.D.) in a relevant scientific field.
• Ph.D. degree is preferred.
• Minimum of 8-10 years medical writing experience.
• Expert knowledge of and experience in preparing high quality clinical and regulatory documents.
• Knowledge of clinical trial disclosure.

Responsibilities

• Lead medical writing for one or more clinical programs, planning, development, and implementation of content strategy for regulatory documents.
• Represent Medical Writing on cross-functional teams and participate in NDA/MAA/IND submission planning.
• Author and manage clinical documents within timelines with high quality in terms of scientific content, organization, and accuracy.
• Drive document strategies with subject matter experts and stakeholders.
• Coordinate work with in-house writers and outside CROs.
• Mentor 1–2 direct reports and oversee writing across a therapeutic area.
• Review deliverables and regulatory documents; ensure consistency and compliance.

Skills

Medical writing leadership

Regulatory writing

Cross-functional collaboration

Regulatory submission planning

Communication skills

Education

MS or PhD in a scientific field

Tools

eCTD starting point

Veeva Vault

Please Review

Smart Sheet

MS Office Suite

SharePoint

Job description

The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Global Medical Writing. The individual will be the lead writer across programs/submissions that are part of the growing clinical pipeline.

In this high visibility role, the individual will be responsible for independently writing and managing clinical study-related documents including, but not limited to, clinical study protocols, master protocols, Investigator's brochures, and clinical study reports. The individual will lead cross-functional teams in development of regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents.

The position reports to the Senior Director, Global Medical Writing.

What You’ll Do:

• Medical Writing lead for one or more clinical programs, leading the planning, development, and implementation of content strategy for clinical and regulatory documents
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentation
• Author and manage the preparation of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Drive document strategies and messages in a collaborative way with relevant project team subject matter experts
• Maintain cutting edge knowledge base of current developments in field and related technologies.
• Incorporate process improvements and changes that align with R&D needs
• Excellent written communication skills, detailed-oriented, self-directed and with the ability to be flexible and manage workload of multiple concurrent projects to meet project timelines
• Plan and coordinate work with in-house Medical Writer team and outside CROs
• Strong team player and a change agent who further reinforces/enhances Deciphera’s cultural values
• Experienced and skilled in performing medical literature searches
• Participate in company-wide initiatives such as leading protocol template working groups or IB standardization across programs.
• Perform reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed
• Manage and mentor 1–2 direct reports, with future oversight of writing across a therapeutic area
• Advanced degree (MS or Ph.D.) in a relevant scientific field. Ph.D. degree is preferred
• Minimum of 8-10 years medical writing experience
• Expert knowledge of and experience in preparing high quality clinical and regulatory documents
• Knowledge of clinical trial disclosure
• Experience in authoring regulatory and clinical documents for global submissions, including strong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in the planning and preparation of summary documents
• Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
• Strong organizational/prioritization skills for the management of multiple concurrent documents
• Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please Review
• Oncology, immunology, and/or neurology experience is highly preferred

Deciphera is committed to fair and equitable compensation practices. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. The estimated base salary for this range is $175,000-$215,000.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.