Senior Director of Medical Writing

Bala Cynwyd, PA, United States

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Description

The Company:

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position:

Senior Director of Medical Writing

Reports to: Chief Medical Officer

Position Summary:

The Senior Director of Medical Writing will be a pivotal cross-functional team member and will be recognized as a subject matter expert in the preparation of regulatory and clinical documents. In this role the Senior Director of Medical writing will apply in-depth knowledge of medical and regulatory medical writing and will lead medical writing activities that support clinical development and regulatory submissions through direct authorship as well as managing external medical writers.

The company maintains an engaging and collaborative relationship with regulatory agencies. Thus, the ideal candidate will have directly applicable experience producing regulatory briefing dossiers that conveys strategic messaging consistent with the objectives of the document.

The Senior Director of Medical Writing will be based at the company headquarters located in Bala Cynwyd, PA. The number of days in the office is flexible and may change over time.

Job Responsibilities:

The responsibilities for the Senior Director of Medical Writing may include but are not limited to the following activities:

* Develop and implement the project plan and timelines associated with the production of high quality clinical and regulatory documents.

* Ensure that all clinical and regulatory documents conform with internal standards and applicable guidelines and regulations.

* Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality Assurance, to align on document content and strategy.

* Establish strategic messaging within the document in accordance with the objectives of the document and ensure consistency of strategic messaging within the document as well as across related documents.

* Review, edit, or write documents or sections of documents as needed.

* Manage internal and external subject matter experts and writers to ensure timely delivery of document components.

* Supervise production of submission-ready documents by the established due date.

* Contribute to the production of relevant Medical Affairs presentation materials.

* Stay abreast of industry best practices and contribute to continuous improvement initiatives within the medical writing function.

* Other writing or editing duties as assigned by the Chief Medical Officer.

Requirements

* Advanced degree in Life Sciences, Pharmacy, or Medicine.

* Extensive experience in medical and regulatory writing within the biotechnology or pharmaceutical industry.

* Proven track record of successful submissions to regulatory authorities (e.g., FDA, EMA).

* Strong leadership skills with experience managing internal staff and external vendors.

* Excellent communication, organizational, and project management skills.

Benefits:

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

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