Job Description

Job Description

This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science that continuously evolves with new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.

The Role:

The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Medical Writing. The individual will be responsible for leading document strategy and development of complex clinical documents across programs/submissions.

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

What You’ll Do:

• Hands-on role focused on writing responsibilities, including acting as the Lead Medical Writer for complex studies/documents such as master protocols, investigator’s brochures, clinical study reports, and clinical summary documents
• Mentor junior medical writers as needed
• Overall responsibility for planning, implementing, and adhering to medical writing timelines for study/program needs
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and preparation
• Strong team player and a change agent who further reinforces/enhances Deciphera’s cultural values
• Excellent collaboration and people management skills with cross-functional partners and broader organization and outside agencies
• Lead/participate in significant workstreams that involve work across departments and with external vendors; may include participation in initiatives such as document templates, process development, automation of safety narratives, , and document reviewing/authoring tools
• Developing and participating in department training and SOP development
• Performing reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed
• Maintains cutting edge knowledge base of current developments in field and related technologies
• Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections

Qualifications

What You’ll Bring:

• PhD or equivalent plus 8+ years of experience, or Masters/Bachelors plus 12+ years of experience
• Extensive experience authoring regulatory and clinical documents for global submissions, including strong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in planning and preparation of summary documents
• Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
• Experience producing high quality clinical documents
• Knowledge of clinical trial disclosure
• 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

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $182,000.00 - $250,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.​

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.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

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.

Job Tags

Similar Jobs