Lead Medical Writer (Fully Remote) - Strategic role for both Regulatory Submissions and Clinical Documents - CNS/Neuro

Reference: JPC544

Expiry Date: 30-04-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

San Francisco County
United States

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Job Description

About our client

We have the pleasure of introducing to you a new Lead Medical Writing role with an extraordinary pharmaceutical company. Our client is on a mission to change the way and redefine modern CNS Drug Discovery and are reinventing the treatment of Psychiatric and Neurological Disorders.

With a number of renowned neuroscientists at the helm they have developed a unique discovery platform with patented innovations that combines cutting edge technologies to successfully develop a strong pipeline of safe, effective therapeutics.

Their leading compounds are already in clinical trials, and their treatments demonstrate promise for multiple indications across the full spectrum of CNS disorders (including social deficits and movement disorders).


My client has offices on the both the East and West Coast, but this role can be fully remote from any location in the US.

The Environment

Their culture is diverse and friendly, with a laid-back enthusiasm and sense of humour that makes collaboration easy, and the leadership team is dedicated, hands-on and available to jump in as needed.

They are passionate about their patients and their care, and they foster an environment that ignites creativity and celebrates leadership and positive stakeholder engagement. Each person here knows their opinion will be respected, and their positive input recognised and rewarded.

About You

Your strategic experience in Medical Writing for both regulatory and clinical documents are needed in this role and you must be able to work independently and seek out information when needed. Neuroscience is important but not essential but early development experience is (needed). This will be one of the early members of a growing Medical Writing team so will want and enjoy working in a smaller, agile team and company where you really do work closely with other stakeholders, but with the responsibility to drive your projects/documents through to completion. You will enjoy helping the department to grow by making suggestions and/or developing new SOP’s, processes and templates and also assessing new technology and software, it’s a work in progress.

About the Role

Reporting to the Vice President of Regulatory Affairs, this will be a key role in the growth of both the Medical Writing and Regulatory Affairs departments. You will be the Lead Medical Writer,  graded Associate Director and the focus  will be on early development, initially in Phases 1 & 2 and compounds coming out of Pre-clinical.

This role will be both Regulatory writer and clinical writer, with a good level of strategic input, but in essence the more you can lead, the more you will be encouraged to lead. You will set up working group meetings to develop progress of the documents; you will be given direction by the VP of Regulatory but expected to take the initiative, to set up the kick off meetings, identify documents needed, timelines, and take leadership responsibility.

This role would not suit someone who just wants to write, but it would suit someone who wants to be involved in shaping the underlying strategies and narratives. Longer term opportunities exist to move from Medical Writing into Regulatory Affairs, into a Global Regulatory Lead position or lead the Medical Writing group as the team starts to grow.

Areas of Focus

  • Collaborates with cross-functional team members, e.g., Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, Pharmacovigilance, publishing vendor, consultants, etc., to ensure accurate and timely completion and delivery of high-quality, accurate, concise, consistent, scientifically-sound documents, slide decks, and publications
  • Documents may include IND modules, nonclinical study reports, investigator brochures (including initial IBs), clinical trials protocols, protocol amendments, informed consent forms, clinical study reports, scientific advice briefing documents, regulatory response documents, and safety updates
  • Provides editorial or review support (or coordinates external resources) for other types of documents or medical communication, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals, Investigator Meeting presentations, site communications, patient information leaflets, etc. to ensure alignment with scientific strategies and corporate goals.

Skills and Qualifications:

  • High-level content writing experience and experience with clinical development regulatory documents required, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Advanced knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
  • Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology.
  • Industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, clinical research, or product support/R&D; regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.

To Apply!

To apply for this role, please contact me, Ivan Nash on +1-908-378-8980 or send a full CV to Ivan.Nash@AdvTalent.com and I will reply by return. Our team will support you throughout the interview and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.