Manager, medical writing job description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success.

Inspiring and nurturing staff to do their best work means a better, healthier future for all. We're a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We're looking for a Manager, Medical Writing to join our Medical Writing team that is passionate about improving healthcare through innovative clinical research.

As a member of the Premier Research team, you'll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
What you'll be doing:
Responsible for the creation of written scientific documentation associated with the clinical trial process including, but not limited to, Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), other regulatory documents, manuscripts, and/or poster, slide, or oral presentations. Responsible for costing medical writing proposals, and for developing project plans and project assignments for all direct reports.

Oversees the day-to-day activities of direct reports Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs Assists in writing Integrated Summaries of Safety and Efficacy (ISS and ISE), New Drug Applications (NDAs), and other regulatory documents necessary for regulatory submission Writes and develops manuscripts and/or posters for publication Creates slides for oral presentations Creates in-text tables and word processing Compiles document appendices, attachments, etc. Reviews documents generated by other medical writers in the department and provides constructive feedback (mentoring) Assists in the review of draft case report forms (CRFs), statistical analysis plans (SAPs), and in blinded data listing reviews prior to database lock and provides feedback to the team when appropriate Conducts background research as necessary for each assigned project, including literature searches Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results Provides project status updates on a regular basis Is responsible for resource planning and allocation as well as selection of new staff
What we are searching for:


Bachelor's degree (or equivalent) in the medical sciences, journalism, or English (MS or PhD preferred) Demonstrated medical/technical writing or clinical research experience Proven supervisory experience Ability to create and manage large electronic files and documents Requires analytical skills and extensive knowledge of medical terminology Ability to facilitate a project team meeting with internal and external team members Familiarity with Microsoft Office as well as Adobe tools (software) and computer graphics
Why ch oose Premier Research?
Premier Research is more than a company - it's a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.


#LI-JD1
#Remote

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 Manager, Medical Writing (MW) Resourcing will be the single point of contact within MW for the identification, procurement, and management of outsourcing needs. The role will be responsible for working with MWs and Document Leads (DL) to proactively identify outsourced resourcing needs to ensure MW meets its book of work. Such outsourced resources may include, but are not necessarily limited to, medical and/or regulatory writers and document quality reviews. The role will work with a select group of freelance and vendor resourcing options, will negotiate and maintain contracts, and will work with MWs and DLs to approve invoices.

Responsibilities

• Working with the MWs and DLs, identify, procure, and manage outsourced resources for MW.
• Manage contracts and perform as the WAND administrator/invoice approver for MW outsourced resources.
• Develop processes for requesting MW outsourced resources, ensuring consistency amongst MWs and DLs.
• Manage the administrative aspects of on-boarding of MW outsourced resources including liaising with IT, Regulatory IT, and Training (LMS/RegOps), including the development and administration of streamlined on-boarding processes.
• As needed, work with DSI Procurement to identify potential new vendors to consider for MW needs
• Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

• Bachelor's Degree Bachelor's degree or Associate's degree with work experience in project management/contracts management/vendor oversight required

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.

• Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documents
• Lead writing team to ensure timely generation of key documents in partnership with the relevant functions (Clinical Study Protocols, Clinical Study Reports, responses to Information Requests from regulatory agencies, major regulatory submissions including Meeting Requests, Meeting Packages, and Marketing Applications, and more)
• Coordinate document writing, review and revision to ensure the highest quality and in alignment with program strategy and objectives. Perform key functional activities as required per deliverable
• Proactively plan future deliverables to ensure organizational alignment and preparation for document reviews in an efficient manner
• Oversight of medical and regulatory writing vendors in alignment with Karyopharm internal resources, methods, SOPs, and overall approach
• Identify critical departmental issues, generate recommended plans to address the critical issues and present recommendations to R&D Leadership team
• Work closely with external subject matter experts, supported by significant preparation, to obtain input required for timely completion of documents
• Develop departmental goals consistent with corporate goals
• Ensure that the medical writing team is fully informed on Karyopharm policies, standards and expectations
• Provide guidance to medical writing team to support career development and resolve intra- and inter-departmental conflicts
• Set expectation (explicitly and by example) for staff and teams to work according to Karyopharm ICARE core values, and to interact with other employees in a professional and respectful manner

Qualifications

• More than 15 years of drug development team leadership experience
• More than 10 years of medical writing
• Post-graduate degree (e.g., PhD, MD, PharmD)
• Experience managing and leading a team of medical writers
• Knowledge of ICH and GCP guidelines and any other regulations relevant to medical writing
• Experience with preparation of NDAs or BLAs and management of NDA-supporting teams
• Experience in oncology
• Ability to effectively manage and motivate teams to achieve corporate, departmental and program goals in a timely fashion
• Ability to effectively manage and motivate staff members to maximize their contributions to Karyopharm and their career development
• Demonstrated abilities in collaboration with others and independent thought.
• Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint and Please Review software.
• Careful attention to document detail and accuracy with high quality and accurate referencing.
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally

Overview

Our Karyopharmers live and demonstrate our ICURE values every day!

#ThisIsWhyKPTI

Karyopharmers 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 (Stock options and 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

*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