New · posted Oct 31
Viking Therapeutics · Biotechnology
Medical Writer
- San Diego, CA
- On-site
- Full-time
- Senior & Principal
The role
Description
The Medical Writer is responsible for planning, authoring, editing, and finalizing high-quality clinical and regulatory documents in support of Viking Therapeutics’ clinical development programs. Reporting to the Vice President, Clinical Development, this role partners closely with internal Clinical Development, Biostatistics, Clinical Operations, Regulatory Affairs, and Pharmacovigilance/Drug Safety teams, as well as with external contract research organizations (CROs) and specialty vendors, to produce phase-appropriate documents from early-stage development through late-stage clinical and pre-approval activities. The Medical Writer will develop clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), safety and periodic reports, and the clinical sections of regulatory submissions, as well as scientific abstracts, manuscripts, and presentations, across Viking’s portfolio, including the company’s lead GLP-1/GIP dual agonist programs (VK2735) and additional metabolic and endocrine disorder pipeline assets. The level of the role will be commensurate with the candidate’s experience and qualifications.
What you need
Education and Experience Requirements
- Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline with 4+ years of relevant regulatory/clinical medical writing experience in the pharmaceutical or biotechnology industry; or an advanced degree (M.S., Pharm.D., or Ph.D.) with correspondingly relevant experience.
- Demonstrated experience authoring clinical-regulatory documents (e.g., protocols, CSRs, IBs, or clinical submission sections) within a GCP environment.
- Title and level will be commensurate with the candidate’s experience and qualifications.
Knowledge and Skills Requirements
- Strong working knowledge of ICH-GCP, ICH E3 (clinical study report structure), the CTD/eCTD framework, and regulatory requirements for clinical documentation.
- Excellent scientific and technical writing skills, with the ability to translate complex clinical and statistical data into clear, accurate, and well-organized documents.
- Advanced proficiency with Microsoft Word (templates, styles, and complex formatting), collaboration and document management tools, and reference/literature management software; familiarity with electronic document management systems.
- Ability to manage multiple documents and competing timelines simultaneously, with strong project-management, organizational, and attention-to-detail skills.
- Experience in metabolic, endocrine, or obesity/GLP-1 therapeutic areas, and/or in a lean biotech that outsources clinical execution to CROs, is a plus.
- Strong interpersonal and collaboration skills; ability to work effectively with cross-functional teams and external partners and to lead document reviews with scientific and executive stakeholders.
Skills named in this posting
What you'll do
Essentials Duties and Responsibilities
The main responsibilities of this role include:
- Author, review, edit, and finalize clinical and regulatory documents – including clinical study protocols and amendments, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), and the clinical sections of regulatory submissions (INDs, CTAs, NDAs) – in accordance with ICH-GCP, applicable regulatory guidance, and Viking standard operating procedures.
- Review safety and periodic reports (e.g., Development Safety Update Reports) and clinical narratives, and support timely, accurate responses to health authority questions in collaboration with Regulatory Affairs and Pharmacovigilance.
- Develop briefing documents and regulatory meeting materials (e.g., pre-IND, End-of-Phase 2, and advisory committee or scientific advice packages).
- Establish and manage document timelines, coordinate cross-functional reviews, and lead comment resolution and document finalization to meet submission deadlines.
- Ensure scientific accuracy, consistency, and adherence to style guides, templates, and document standards across the clinical document set.
- Manage medical writing deliverables outsourced to external CROs, contract medical writers, and vendors; provide direction, review, and quality oversight of outsourced documents.
- Maintain compliance with ICH-GCP, applicable FDA and EMA regulations, and data integrity (ALCOA+) and good documentation practices; support version control and archival within the electronic document management system.
- Contribute to the development and continuous improvement of medical writing templates, style guides, and standard processes.
- Other duties as assigned.
Pay
$100,000 – $125,000 a year
Employer providedSalary Description
$100,000.00 - $125,000.00 annual salary
Where you'll work
San Diego, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in San Diego, CAEqual opportunity, accessibility and legal noticesViking Therapeutics's statements, word for word
VIKING THERAPEUTICS
Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Notice to Agency and Search Firm Representatives
Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. #LI-DNI
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 40% below the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Senior & Principal roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $100,000 | — | $125,000 |
| All US (middle half) | $162,375 | $186,000 | $205,875 |
This role: Viking Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 21 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Viking Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs16
- Regulatory submissions7
- GMP and compliance6
- Clinical trial conduct6
- Collaboration and leadership6
- Investigations and CAPA2
- Data and digital systems2
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Viking Therapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Clinical4 67%
- Regulatory1 17%
- Quality1 17%
By level
- Director2 33%
- Manager2 33%
- Senior & Principal1 17%
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Medical Writer at Viking Therapeutics
Open until filled. $100K–$125K a year, employer provided.