Director, Medical Writing
Karyopharm TherapeuticsRole Overview & Key Functions:
The Director, Medical Writing will take lead in preparation of different types of clinical and regulatory documents and will oversee the writing of clinical documentation in support of clinical development (e.g., protocols, IBs, CSRs, etc.) and regulatory filings (e.g., clinical modules in IND and NDA). They will mentor other medical writers, drive key operational workstreams, ensure all documents adhere to established program strategy, and provide key recommendations for improved outcomes.
Responsibilities:
- Write or supervise writing of complex clinical study−related documents, including protocols, protocol amendments, Investigator Brochures and clinical study reports to support Karyopharm clinical development programs. This will include generating questions about technical content, identification of key subject experts to address the questions and providing informed updates to the documents.
- Write or supervise writing of regulatory documents including health authority meeting requests, briefing books, regulatory filings including NDA, IND, and Assessment Aids for submissions, where applicable.
- Ensure all content is high-quality and consistent with program strategy, and where possible provide recommendations for content enhancements and optimization for team consideration.
- Adjudicate cross-functional feedback, drive consensus, and reconcile diverse viewpoints via stakeholder management and facilitating comment resolution forums.
- Serve as mentor to other medical writers and leverage prior experience to help build capabilities and co-develop junior talent.
- Champion and lead operational workstreams as subject-matter expert to develop new internal guidance and improved practices for other medical writers.
- Working with the Head of Medical Writing, develop medical writing processes, standards, and innovative initiatives.
- Work in a collaborative manner with team members from various functional groups.
- Solves problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
- knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
- Coordinate review and approval of oncologic clinical study-related documents.
- Contribute to creation and maintenance of templates and standard text for clinical documents.
- Significantly contribute to discussions regarding document content, informed by review of pertinent publications, guidance and/or discussions with outside experts.
Candidate Profile & Requirements:
- More than 7 years of Medical Writing experience with evidence of increasing responsibility/technical development.
- Experience writing Clinical Overviews and Integrated Summary of Safety/Efficacy in BLA/NDA submissions to Health Authorities
- Experience in managing medical writers preferred
- Knowledge of regulations relevant to medical writing within oncology.
- B.S. or equivalent degree in a scientific area. Advanced degree (MS or PhD) preferred.
- Ability to assess workload and suggest prioritization to senior staff.
- Demonstrated abilities in collaboration with others and independent thought.
- Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint and document reviewing software.
- Ability to work on several projects in parallel balancing multiple and overlapping timelines.
- Careful attention to detail and accuracy.
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
At Karyopharm, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity. We maintain broad salary ranges to reflect market conditions and the specialized nature of our work. The anticipated base salary range for this position is $200 K –$220 K USD.
Our Value Proposition:
At Karyopharm, we live and demonstrate our ICARE values every day! If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission.
Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between.
What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.
Check out our Culture Video!
What We Offer:
In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.
- A culture of employee engagement, diversity, and inclusion
- Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
- Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
- Wellness Program with a monthly stipend.
- Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
- Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
- Cell phone allowance