Director, Medical Writing

Xenon Pharmaceuticals Inc.; Boston (MA); On-site; USD 215,000 - 230,000; Full time

Job summary

Join a forward-thinking biopharmaceutical company as a Director of Medical Writing. This role offers the chance to shape medical writing processes and lead a dynamic team in a hybrid work environment. You will drive innovative strategies for regulatory submissions, ensuring the highest standards in clinical documentation. With a focus on collaboration and excellence, you will contribute to groundbreaking research aimed at improving lives through advanced therapeutics. If you possess outstanding writing skills and a passion for neuroscience, this is your opportunity to make a significant impact in the field.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Retirement Savings Program

Tuition Assistance

Employee Assistance Program

Vacation Days

Sick Days

Personal Days

Company Shutdown

Qualifications

• 10+ years of management & clinical writing experience required.
• Expertise in regulatory documentation and submissions is essential.
• Exceptional writing and leadership skills are a must.

Responsibilities

• Lead medical writing activities and manage a team.
• Develop essential clinical documents for regulatory submissions.
• Ensure timely completion of writing assignments and projects.

Skills

Clinical Writing

Leadership

Regulatory Submissions

Critical Analysis

Interpersonal Skills

Communication Skills

Education

Undergraduate Degree

Tools

Microsoft Word

PowerPoint

EndNote

Job description

Who We Are:
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:
We are seeking a Director, Medical Writing to join our team. The Director, Medical Writing works to drive and shape the medical writing processes, strategies, and document generation and maintenance. The position will lead medical writing activities and manage a team. The Director will work flexibly across a number of preclinical and clinical stage projects, providing medical writing expertise and oversight, including data review. To be successful, the candidate will be a strong communicator, will be able to maintain excellent collaborative working relationships, and will have outstanding clinical writing skills.

This position reports to the Senior Director, Medical Writing and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Relocation and immigration support will be provided, if required. This role is a hybrid position, requiring a minimum of 2 days per week in the office.

RESPONSIBILITIES:

• Provide strategy and support in the best practices of medical writing for the development organization.
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and act as the Medical Writing lead in IND/NDA submissions.
• Lead Medical Writing and cross-functional process improvement initiatives on document standards, template development, and document processes.
• Plans, writes, edits, and formats essential clinical development documents, including but not limited to: protocols, Investigator's Brochures, clinical study reports, narratives, IND and NDA modules, and briefing documents.
• Maintains timelines and workflow of writing assignments and ensures timely completion.
• Manages projects from start to completion, including the efficient review and finalization of documents produced.
• May act as the lead writer in a program; strategizes with cross functional team to prioritize documents and ensure timely completion.
• Represents Medical Writing on multiple project teams and serves as subject matter expert for clinical development documents.
• Works collaboratively within a team environment and interacts directly and independently with all relevant groups.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices. Interviews, mentors, and assists in the integration of medical writing staff as needed.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.
• Other duties as assigned.

QUALIFICATIONS:

• Minimum undergraduate degree. 10+ years of relevant management & clinical writing experience or combination of degrees and experience.
• Recognized as a subject matter expert in a broad range of regulatory documentation.
• Strong leadership presence with demonstrated ability to lead without authority and to influence programs, projects, and/or initiatives.
• Ability to analyze critically and synthesize complex scientific information from a range of clinical therapeutic areas.
• Experience in leading regulatory submissions presented to Health Authorities (e.g., Investigator’s Brochures, clinical study reports, and IND and NDA summary modules).
• Exceptional writing skills.
• Proven leadership skills including supervision of direct reports.
• Proven organizational skills and the ability to work across a variety of teams and manage multiple competing priorities.
• Expert in Microsoft Word, PowerPoint, and related word processing and electronic publishing tools.
• Experience with EndNote and StartingPoint templates desired.
• Comprehensive knowledge and understanding of ICH-GCP and US, Canadian, and EU regulatory environments; previous experience with CTA, IND, and NDA submissions preferred.
• Excellent oral and written communication skills.
• Good interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

The base salary range for this role is $215,000 to $229,700 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.

US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.