Associate Director, Medical Writing, US Remote

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Overview

The Associate Director, Medical Writing leads medical writing of clinical development documents and is recognized as a significant scientific contributor and subject matter expert in preparation of documents to support POINT Biopharma’s clinical development programs for submission to clinical sites and Health Authorities. The Associate Director, Medical Writing, reports to the Sr. Director, Medical Communications in Clinical Development.

Accountabilities

The Associate Director, Medical Writing is responsible for writing, editing, and formatting study-and program-level documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, study manuals, sponsor positions, and clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents.

Objectives

• Lead the management and authoring of program-level and study-specific documents, including protocols, protocol amendments, investigator brochures, clinical study reports, and other documents needed to support regulatory interactions and filings.
• Lead internal and external subject matter expert reviews of documents and effectively manage the editing and revision process.
• Review medical writing deliverables to ensure consistency, accuracy, and clarity.

• Provide strategic guidance in developing the statistical outputs required for subsequent clinical regulatory documents and publications.
• Serve as the functional area representative on clinical study teams and advise teams on timelines, content, and format requirements for documents.
• Adhere to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures (SOPs), work practices and approved templates.
• Assist with managing timelines and review cycles, developing content for, formatting, and submitting publications as needed, including manuscripts for peer-reviewed journals, and abstracts, oral presentations, and poster presentations for medical/scientific congresses and industry meetings in collaboration with internal clinical study teams and external researchers and/or scientists.
• Develop departmental infrastructure, processes, templates, and trackers, in collaboration with other functional areas. Assist in the development of SOPs and work practices.
• Monitor, track, and report program status to key stakeholders including senior management.
• Actively work to foster an environment of effective and collaborative working relationships among employees, management, and external partners.

Requirements

• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent with a minimum of 15 years related experience or an equivalent combination of education and experience. Advanced degree such as MPH or PhD preferred.
  
• Oncology experience required.
• Minimum 12 years working in industry.
• Must have led the medical writing team on at least two prior INDs or CTAs.
• Must have written at least two phase I oncology protocols and study reports.
• Must have written at least two investigator brochures.
• Strong analytical skills: ability to understand and interpret complex clinical and scientific data and formulate those data into content in a well-thought out and reviewer‑friendly manner.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to