Director, medical writing job description

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Reporting to the Head of Medical Writing, the Director, Medical Writing - Clinical will play an essential role within Rocket's gene therapy programs, working with both clinical and regulatory teams to optimize the authorship of material related to the development of our AAV and LV programs. The ideal candidate will have experience generating clinical protocols and supporting documents such as investigator brochures, health authority annual reports, and DSURs for health authority submissions in addition to IND applications and clinical study reports. Experience with cell- or gene-based or other highly complex therapies and with multi-systemic, life-threatening disorders is essential. This is an opportunity to establish and build the medical writing capability within an innovative and growing organization dedicated to the development of transformative therapies for serious disorders.
Responsibilities:
Work with clinical and regulatory teams to write and/or revise key technical documents and oversee report writing activities for projects including protocols, amendments, IND applications, clinical study reports (CSRs) and additional regulatory submission documents to support BLA filing
Provide appropriate background information, guidance, and training to colleagues participating in document authorship
Ensure consistency across documents and improve document quality
Review statistical analysis plans and ensure appropriate incorporation into reports
Build and maintain knowledge base to improve the overall medical content of documents
Drive the clinical study report writing process by ensuring that report contributors understand their responsibilities, timelines are developed and maintained and that relevant activities are completed.
Collaborate effectively across Clinical, Regulatory and Quality in a team environment.
Requirements:
Minimum BS in Biological Sciences or related field with 12 years of experience
Experience in protocol development with novel therapeutic agents and therapies directed at complex, multi-systemic disorders; experience with cell therapies and/or gene therapies is preferred
Working knowledge of US FDA and European regulatory requirements
Experience with IND and primary authorship of key components (i.e. CSRs). Experience with BLA packages preferred.
Ability to operate in a fast-paced, collaborative environment
Ability to perform work with a high degree of accuracy and quality while working under tight deadlines.
Strong verbal, written, and interpersonal communications skills with the ability to explain complex concepts with clarity and simplicity.
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) and Adobe Acrobat Professional.
A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The primary responsibilities of this position are to write, with minimal supervision of the lead author (Director, Medical Writing) complex documents including BLA/MAA submission documents (eg, Summary of Clinical Safety) and responses to HA requests for information. This position will contribute to strategy development for document authoring, and contribute strategically and scientifically at the study team level. The Associate Director, Medical Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).

Responsibilities

• Write critical, complex clinical documents (eg, pivotal Phase 3 study protocols and reports, NDA/BLA/MAA submission documents) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents; support the lead author (Director, Medical Writing) in the search of scientific literature to place study results in context with other relevant data
• Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency
• Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents
• Participate in initiatives with Medical Writing Group in Japan and the EU to identify Medical Writing process improvement opportunities, potential collaborations and drive changes as needed etc.
• Aid Director, Medical Writing in determining resource needs, proactively identify issues and solutions, and contribute to timelines and processes

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Experience Qualifications

• 4 or More Years of experience as a medical writer with a graduate degree in a relevant science field preferred or
• 7 or More Years of experience as a medical writer with a Bachelor's degree in a relevant science field preferred
• Regulatory Medical writing experience required
• Submission document writing experience preferred

Travel

Ability to travel up to 5% In-house/remote office position that may require domestic/global travel.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

• Master's Degree in a scientific discipline. Doctorate degree preferred.
• At least 12 years of experience in pharmaceutical or biotech industry in medical/regulatory writing operations including at least 4 years of experience leading teams
• Strong background showing progressive MW operations, experience, including staff management
• Previous outsourcing management experience preferred
• Ability to understand and utilize new technology and new systems in medical writing
• Experience with ICH, eCTD, submission requirements for clinical/research reports, along with an understanding of electronic submissions requirements
• Strong written/verbal communication skills, detail-oriented nature
• Excellent leadership and influencing skills
• Demonstrated project management skills
• Ability to provide direction with cross-functional teams in a matrixed team environment
• Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn .

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

• An entrepreneurial attitude is encouraged
• Our people are empowered to speak up, embrace the gray and achieve solutions
• Diverse experiences are an important of part making the best decisions
• We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies : Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

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