Sr. Manager, Global Medical Writing

3 days ago

Watertown, United States Deciphera Pharmaceuticals Full time
Company Description

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.

See here for more details on our portfolio.

We offer an outstanding culture and opportunity for personal and professional growth guided by our "PATHS" Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.

Job Description

The Role:

The Global Medical Writing team is seeking an experienced and self-motivated individual with a strong understanding of the current medical writing landscape and a commitment to document excellence. As the Senior Manager, Global Medical Writing, you will play a key role in Deciphera's dynamic portfolio and be part of the expanding GMW&CTD department.

In this role, you will lead and ensure the effective planning and preparation of complex documents across multiple programs. You will work collaboratively and cross-functionally to produce high-quality, submission-ready documents on time to support regulatory submissions. This position supports both early and late-stage development programs and regulatory submissions.

The position reports to the Director, Global Medical Writing.

What You'll Do:
  • Serve as the lead medical writer for one or more programs, contributing to a variety of clinical documents, including (but not limited to) clinical protocols, clinical study reports, investigator brochures, module 2 clinical summaries, and module 5 integrated summaries of efficacy and safety.
  • Act as a medical writing subject matter expert and work with cross-functional team to produce high-quality, scientifically accurate documents.
  • Author and manage the completion of clinical documents and other assigned tasks within established timelines and department SOPs 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.
  • Communicate with team stakeholders to maintain awareness of program/regulatory strategy, expectations, milestones, and deliverables.
  • Have at least one direct report and/or manage the work of CRO consultant writers, as needed.
Qualifications

What You'll Bring:
  • PhD in a Life Science or equivalent preferred, Master's or Bachelor's degree considered based on experience level.
  • 5-7 years of industry experience as a Medical Writer including 2 years as a lead writer. Experience managing people (up to 2 years) in an established Medical Writing group is desirable.
  • Knowledge of ICH regulations, requirements and guidance associated with regulatory document preparation, submissions, and industry trends for dossier preparation.
  • Excellent written and verbal communication skills, detailed oriented, self-directed and with the ability to be flexible and manage multiple and changing priorities, work under pressure, and adhere to deadlines.
  • Proven ability to understand and interpret clinical study output; summarize complex results and present them in a clear, concise, and scientifically accurate manner dependent on audience.
  • Leadership role on complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA) is preferred.
  • Intermediate-to-advanced negotiation skills to coordinate the efforts of cross-functional teams.
  • Technical expertise in state-of-the-art medical writing standards, templates, and necessary electronic systems (eg, PerfectIT, EndNote, Please Review, SharePoint, Veeva, etc.).
  • Working knowledge of clinical disclosure and redaction requirements across ICH regions.
Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
  • Non-accrual paid time off
  • Summer vacation bonus
  • Global, company-wide summer and winter shutdowns
  • An annual lifestyle allowance
  • Monthly cell phone stipend
  • Internal rewards and recognition program
  • Medical, Dental, and Vision Insurance
  • 401(k) retirement plan with company match
  • Life and Supplemental life insurance for family
  • Short and Long Term Disability insurance
  • Health savings account with company contribution
  • Flexible spending account for either health care and/or dependent care.
  • Family planning benefit
  • Generous parental leave
  • [if applicable] Car allowance

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.

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