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Medical Writer

Full-Time
at
Company Location:
Indianapolis
,
US
Job Location:
Remote (Canada)
Indianapolis
,
US
Level:
Senior
Pay:
$
0.00
(
)
Category:
Medical
Posted on:
May 6, 2022
Might be expired
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Job Description

The Senior Medical Writer 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.

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 CANADA.

Location Of Work

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

The Senior Medical Writer 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 Senior Medical Writer reports to the EVP, Clinical Development.

The Senior Medical Writer is responsible for writing, editing, and formatting study-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.

Responsibilities

  • Leads the process and authoring of program-level and study-specific documents, including protocols, protocol amendments, Investigator’s Brochures, clinical study reports, and other documents needed to support regulatory interactions and filings.
  • Leads the process and authoring of publications, 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.
  • Conducts peer-review of medical writing deliverables to ensure consistency, accuracy, and clarity of all documents.
  • Collaborates with key functional areas to provide strategic guidance in developing statistical outputs required for a variety of clinical regulatory documents and publications.
  • Serves as the functional area representative on clinical study teams and advises teams on content and format requirements for documents.
  • Adheres to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures (SOPs), work practices and approved templates.
  • Assists in the development of SOPs and work practices.
  • Develops departmental infrastructure, process documents, templates, and trackers in collaboration with other functional areas.
  • Monitors, tracks and reports program status to key stakeholders including senior management.
  • Actively works 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 7 years related experience or an equivalent combination of education and experience. Advanced degree such as MPH or PhD preferred. Oncology experience required.
  • Must have led the medical writing team on at least two prior INDs or CTAs
  • Must have written at least 2 phase 1 oncology protocols and study reports
  • Must have written at least 2 investigator brochures
  • Proficient in English
  • Fundamental knowledge of data and statistical presentations
  • Certified by the American Medical Writers Association, or equivalent.
  • Experience authoring various early to late-stage clinical development documents such as IND, CTA, protocol, investigator brochure, briefing documents, etc.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Solid understanding of scientific methods, science and medical terminology in the area of oncology.
  • Technical expertise in nonclinical and clinical oncology studies.
  • Exceptional oral and written communications skills and the ability to organize and present complex material clearly, concisely, and effectively.
  • Extensive knowledge of English grammar.
  • High standard for quality, excellent attention to detail and a methodical, diligent approach to proofreading, ensuring consistency in style, grammar, and punctuation.
  • Experience and skill in document layout and formatting with keen attention to detail.
  • Proficiency with MS Office and Adobe Acrobat.

Competencies

  • Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment
  • Motivated learner who is looking to advance own expertise and value
  • Expert proficiency in Word and Adobe
  • Ability to understand new scientific concepts and information and apply these in a changing environment
  • Inherent drive to cultivate collaboration, teamwork and professionalism
  • Organized with high attention to detail, accuracy and completeness

Why joining POINT today will be the right career move for you:
There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

  • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
  • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
  • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
  • Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a cover letter and resume.

Benefits

  • Healthcare (medical, dental, vision)
  • Life insurance
  • Disability
  • $500 fitness reimbursement per year
  • $50 cell phone reimbursement per paycheck

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.

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