Medical Writing Associate

Full Time
Remote
$80,500 - $149,000 a year
Posted
Job description
Responsibilities:
Reporting to the Head of Medical Writing, this candidate will support large global Regulatory Submissions and clinical and non-clinical documents. Responsibilities will include:
  • Manage the flow of narratives through the development process
  • Support Medical writers with coordination of various documents and submissions
  • Ensure vendors have material needed for submission completion
  • Track the progress of documents according to deadlines and milestones
  • Some QC of documents as requested
  • Other document management duties (formatting, etc)
  • Administrative management of clinicaltrials.gov
Qualifications:
  • At least 3 years of Medical Writing experience with evidence of increasing responsibility/technical development
  • BS or equivalent degree in a scientific area. Advanced degree (MS, PhD, PharmD, or MD) preferred
  • Knowledge of ICH regulations relevant to medical writing
  • Demonstrated ability to work in collaboration with others and lead cross-functional team meetings
  • Ability to understand/interpret statistical outputs summarizing data collected during clinical trials
  • Experience in developing summary documents included in regulatory submissions (eg, NDA, BLA, MMA) is a plus
  • Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft Powerpoint and SharePoint
  • Ability to successfully multitask; working on multiple projects at the same time with 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
Overview:

At Karyopharm, we live and demonstrate our ICARE values every day!


We are passionately driven in our mission to positively impact patients’ lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers 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 fun, collaborative, work environment
  • 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), and tuition reimbursement.
  • 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 programs, and a variety of reward and recognition programs)
  • Cell phone allowance
  • In the U.S., the salary range for this position is $80,500 to $149,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors
  • Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment

  • This position is eligible for remote/hybrid working arrangement (may work from home/virtually; may also work hybrid on-site-virtual as required/approved by hiring manager.

ABOUT KARYOPHARM

WE ARE COMMITTED TO DE&I

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