POSITION SUMMARY

Director, Medical Writing works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service providers to develop Regulatory documents, including but not limited to clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions, integrated summary reports, NDA/MAA and eCTD submissions, and Investigator Brochures, etc.

JOB FUNCTIONS/RESPONSIBILITIES

• Participate in and oversee vendors for the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.
• Work collaboratively to incorporate/adjudicate comments from internal and external stakeholders through document development to produce final high-quality deliverables.
• Interact with internal stakeholders and with external service providers to ensure the timely development, review, and publication of documents.
• Critically analyze complex data and information and collaborate with clinical, medical, and biostatistics/data science teams on data analysis, description, and presentation.
• Coordinate the development of the documents named above and others as assigned by the Head of Medical Writing.
• Ensure quality control of documents as well as formatting finalization.
• Provide support in development of submission-level documents.
• Ensure adherence to timelines.
• Assist the Head of Medical Writing in coordinating workload and maintaining a high standard. Effectively manage multiple assignments in parallel.
• Prepare documents in accordance with Mirum SOP and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
• Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
• Inform management of medical writing problems promptly and propose solutions.
• Provide advice on medical writing issues to project team members (internal and external) and help to resolve problems.
• Represent department in audits and interdepartmental working groups.
• Develop and maintain in-depth scientific, medical, and technical knowledge relevant to Mirum’s clinical studies and pipeline.
• Develop strong relationships with external advisors.

QUALIFICATIONS

Education /Experience:

• An advanced degree with minimum of 8-10 years of experience in medical writing in the pharmaceutical, biotech, medical communication agency industry.
• Excellent writing ability with strong editorial and formatting skills.
• Fluency in written and spoken English.
• An independently motivated working style with good problem-solving skills that allow analysis, synthesis, and compilation of data from a broad range of disciplines.
• Experience managing vendors.
• Rare disease or liver disease background highly desirable.

Knowledge, Skills and Abilities:

• Have a demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
• An ability to work in a fast-paced, cohesive, collaborative team-oriented work environment.
• Self-directed and solution oriented.
• Extensive knowledge of FDA and ICH regulations and guidelines, as well as familiarity of AMA Style Guide and Chicago Manual of Style.
• Strong proficiency in Word, Excel, PowerPoint, and other applications.
• Ability to demonstrate a familiarity with principles of clinical research and interpret and present clinical data and other complex information.
• A demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines.

The salary range for this position is $230,000 to $245,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Senior Director, Global Regulatory Affairs will play a significant role in providing regulatory strategic leadership on multiple clinical development programs associated with rare diseases in assigned Therapeutic Area (TA). This role will represent the regulatory function and provide guidance to Program Teams across the organization which include Clinical Development, Clinical Operations, Biometrics, Nonclinical Science, Drug Safety and Pharmacovigilance, and Quality Assurance for assigned projects. This role will be the Global Regulatory TA Lead, responsible for ensuring global regulatory compliance and overseeing timely delivery of submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities for multiple projects. 

JOB FUNCTIONS/RESPONSIBILITIES

• Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project.
• Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team.
• Oversees/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
• Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy.
• Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
• Actively participates in Health Authority meetings.
• Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management.
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams.
• Effectively manages direct report(s) and provide mentorship to junior professionals.

QUALIFICATIONS

• Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable.
• A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
• Experience in all phases of development and post marketing activities is highly preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding people management skills are required.
• Outstanding interpersonal and communication skills.
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required.
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams.
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
• Supports the SVP, Global Regulatory Affairs as required.

Work Environment:

• This is a high-growth, fast-paced organization. The ability to be productive and a team player is critical.
• Ability to work under minimal supervision.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.
• On site presence at the headquarter is required (minimum 2 days a week).

The salary range for this position is $289,000 to $320,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSTION SUMMARY

The Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. The position will be responsible for all CMC-related submissions: strategic planning, execution, and ensuring quality and accurate supporting documents are submitted within the agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss CMC data within cross-functional teams and with Health Authorities.

JOB FUNCTIONS/RESPONSIBILITIES

• Oversees the development and implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments, and global development programs across Mirum portfolio.
• Directly leads the regulatory CMC strategy for assigned projects.
• Responsible for ensuring the appropriate execution of all regulatory CMC strategies.
• Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
• Ensures the effectiveness of the Regulatory CMC team in developing submissions and in working across functions.
• Clearly articulates regulatory challenges/risks, identify potential solutions, leads the preparation of risk assessments on regulatory CMC topics, and effectively oversees change controls
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensures CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
• Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC.
• Supports regulatory submissions (NDA, MAA, etc.), Briefing Packages, and response documents for Health Authority interactions and address questions/requests, as well as annual updates (e.g., IB, NDA ARs, IND ARs).
• Previous experience leading CMC discussion during meetings with Health Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs.
• Effectively manages direct report(s) and provides mentorship to junior professionals.

QUALIFICATIONS

Education/Experience:

• A minimum of 12 years of relevant experience in Regulatory Affairs CMC.
• Experience in drug development focused on market applications (NDA, sNDA, MAA and variations), investigational applications (INDs, CTAs) and commercial lifecycle.
• Advanced degree in a relevant scientific discipline required, PhD in chemistry or other relevant scientific field is a plus.
• Must have experience with small molecules and biologics regulatory CMC activities, late-stage development through commercialization.
• Combination product experience/knowledge preferred.
• Demonstrated track record of successful submissions to FDA and/or other Health Authorities, including EMA. Regulatory experience/exposure to Japan and China is a plus, and other regions/countries (e.g., Canada, LATAM, MENA, Australia/NZ) is a plus.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent interpersonal, verbal and written communication skills as well as the ability to effectively partner with and influence others are essential in this collaborative work environment.
• Outstanding people management and mentorship skills are required.
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
• Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities.

Work Environment:

• This is a high-growth, fast-paced organization. The ability to be productive and a team player s critical.
• Ability to work under minimal supervision.
• Willingness and ability to travel domestically and internationally is required. It is anticipated that this will be 5-10% of work time.

The salary range for this position is $280,000 to $310,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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