Job Application for Senior Manager, Medical Writing at Ultragenyx Pharmaceutical

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Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Sr Manager, Medical Writing will be responsible for the end-to-end development of various clinical and regulatory documents. The Sr Manager, Medical Writing will work closely with cross-functional teams to develop content and ensure documents are of high quality and completed in a timely manner compliant with SOPs and ICH/GCP/regulatory guidelines.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

Leads/supports development (including authoring, editing, coordinating reviews, QC, finalization) of clinical and regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, eCTD clinical summaries, briefing books, IRs)
Drives cross-functional collaboration in the preparation of clinical and regulatory documents, including alignment on content and messaging, effective conduct of roundtable meetings, resolution of feedback/comments
Distills large amounts of clinical and scientific data into clear, consistent messaging that aligns with program strategy
Adheres to departmental procedures and practices and applies ICH/GCP/regulatory guidelines and industry standards to document development
Contributes to developing/implementing processes and best practices within the Clinical and Regulatory Writing department
Represents Clinical and Regulatory Writing department on various cross-functional teams

Requirements:

BS or MS in a scientific or medical field
5+ years of relevant medical writing experience in the biotechnology/pharmaceutical industry
Demonstrated experience in development of clinical and regulatory documents; least one eCTD submission strongly preferred
Ability to interpret and create complex tabular and graphical clinical data presentations
Exceptional oral and written communication skills
Capable of working on multiple tasks and shifting priorities
Demonstrated flexibility and adaptability to changing strategy and timelines
Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
Demonstrated proficiency and experience with Microsoft Office Suite and Veeva Vault; StartingPoint template, EndNote, Smartsheet, AI tools is a plus
Knowledge of drug development stages, clinical research concepts, regulatory and ICH guidelines as applicable to document writing
Rare disease experience is a plus

#LI-CS1 #LI-Remote

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range

$170,200 - $210,200 USD

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· Generous vacation time and public holidays observed by the company

· Volunteer days

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Employee wellbeing benefits

· Fitness reimbursement

· Tuition sponsoring

· Professional development plans

* Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

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Senior Manager, Medical Writing

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