Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges.Join us!
This Principal/Sr. Principal Medical Writer works under the direction of senior Alpine medical writing staff to support clinical and regulatory communication efforts.
Duties and Responsibilities
- Provides medical writing support to assist in the development and authoring of the following:
o Clinical protocols, patient lay summaries, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings
o Briefing documents, information requests, nonclinical summaries, and additional documents intended for submission to HAs
o Other writing projects as assigned.
- Act as in-house liaison for projects assigned to contract medical writers
- Mentors more junior medical writers
- Works with department head to plan and coordinate regulatory submissions, including INDs and BLAs
- Facilitates document review committee meetings and issue resolution
- Assists other team members with document development and related supportive tasks as needed, including conducting literature searches; formatting of figures, tables, and reference citations; and proof‐reading/editing documents in accordance with the company style guide
- Performs detailed quality control review checks of clinical and regulatory documents, tables, publications, annual reports, literature summaries, submission sections, and internal documents
- Works with Clinical Operations and contract medical writers to compile CSR appendices for publisher
- Works with IT and regulatory operations to manage and update templates, improve submissions processes, and implement new technologies when appropriate
Qualifications
- Minimum of 8 years of experience in the biopharmaceutical industry, with minimum of 6 years of direct medical writing experience
BA/BS required; master’s or doctorate degree in life sciences preferred
- Excellent written and verbal communication skills with the ability to interpret and present scientific data concisely, accurately and with attention to detail
- Ability to work cross‐functionally and build positive professional relationships
- Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat
- Awareness of FDA regulations, EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process
- Awareness of American Medical Association Manual of Style
- Must have the ability to coordinate and prioritize multiple projects in a fast‐paced environment with limited supervision
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At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Principal level position, with a compensation range of $150,000 - $175,000 for a Principal role or $170,000 - $190,000 for a Senior Principal role. In order to be considered for a position, candidates must be located in one of the following five states: CA, MA, NC, OR, or WA . We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.
Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.
Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
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