Talent.com
Associate Director, Medical Writing
Associate Director, Medical WritingTalentBurst, Inc. • San Francisco, CA, US
Associate Director, Medical Writing

Associate Director, Medical Writing

TalentBurst, Inc. • San Francisco, CA, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.permanent]
[job_card.job_description]

Job Description

Job Description

Associate Director, Medical Writing

San Francisco CA, 94158

10 Months (Possible Extension)

Description : Duties :

Summary :

This position will report to the Medical Writing Department Head and will lead scientific, medical and regulatory writing activities for development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs). The professional will also perform the medical writing, QC reviews, and editing of the documents and will be responsible for the management, planning and direction of a team of medical writers. The professional will ensure the timely presentation / dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and supported by appropriate data. This job contributes to and supports the company’s research and development efforts to create high value therapeutics to address medical needs.

Essential Duties and Responsibilities :

  • Manages all clinical writing activities outlined in the Project Clinical Development Plans
  • Reviews documents, offers guidance, and takes lead in creating and managing the document timelines in the preparation of regulatory and publication documents
  • Organizes, conducts, and leads document production meetings and other meetings as necessary. Creates the agendas and minutes to document meetings according to SOPs
  • Manages the oversight of CT.gov updates and when required enters CT.gov updates directly into the system including data entry when necessary
  • Projects Medical Writing assignments, resource allocation, and timeline requirements for CDP
  • Responsible for implementing the departmental guidelines, writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, and IND sections

Remote work, must be available PST time zone but offsite location is flexible.

Skills :

Minimum Qualification Requirements :

  • A minimum of 10 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 8 years writing management experience is also required. A minimum of 10 years previous supervisory experience is required.
  • Demonstrated experience as a primary author writing protocols, IBs, CSRs, IND / NDA sections and other regulated documents. Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents. Knowledge of CTD format.
  • Strong analytical and strategic thinking skills with the ability to implement.
  • An ability to create effective presentations from raw data is essential.
  • An ability to interpret statistical and clinical data is essential.
  • Must have an ability to work well with others in high-pressure situations.
  • Must have demonstrated problem solving abilities.
  • Strong organizational skills are required.
  • Experience managing CT.gov and other registries for clinical trials
  • Strong written and verbal communication skills are required. An understanding of clinical research, biostatistics, and regulatory affairs is required.
  • Excellent computer skills are required. Working knowledge of MS word, Excel, Power point is required. Omnicia template and PleaseReview experience preferred.

    • Education :

  • A Bachelors / Masters degree in a scientific discipline with a strong medical writing background is required. PhD. in a scientific or life sciences discipline preferred.

    • #TB_PH

    #ZR

    Company Description

    Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

    Company Description

    Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

    [job_alerts.create_a_job]

    Associate Director Medical Writing • San Francisco, CA, US

    [internal_linking.similar_jobs]
    Executive Director, Medical Writing

    Executive Director, Medical Writing

    BridgeBio • San Francisco, CA, United States
    [job_card.full_time]
    When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement. In 2015, we pioneered a “moneyball for biotech” app...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Scientific Communications

    Associate Director, Scientific Communications

    Encoded Therapeutics • San Francisco, CA, United States
    [job_card.full_time]
    Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery.We focus on delivering life-changing advances for individuals with genetic disorders not addressa...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Director of Medical Writing

    Director of Medical Writing

    VirtualVocations • Oakland, California, United States
    [job_card.full_time]
    A company is looking for a Director, Medical Writing.Key Responsibilities Oversee cross-functional communication and deliverables for multiple projects, ensuring timely and high-quality document ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Medical Affairs Analytics & Insights

    Associate Director, Medical Affairs Analytics & Insights

    REVOLUTION Medicines • Redwood City, CA, United States
    [job_card.full_time]
    Associate Director, Analytics & Insights.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addict...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Clinical Science

    Associate Director, Clinical Science

    Menlo Ventures • San Francisco, CA, United States
    [job_card.full_time]
    Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics.We are seeking a D...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Medical Director / Medical Director, Oncology

    Associate Medical Director / Medical Director, Oncology

    Corcept Therapeutics • Redwood City, CA, United States
    [job_card.full_time]
    Associate Medical Director / Medical Director, Oncology.Redwood City, California, United States.Corcept is leading the way in the research and development of cortisol modulators, molecules that regul...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Medical Director, Pediatric Specialty Care

    Associate Medical Director, Pediatric Specialty Care

    PACKARD MEDICAL GROUP, INC. • Menlo Park, CA, United States
    [job_card.full_time]
    Associate Medical Director, Pediatric Specialty Care.PMG) is actively recruiting an Associate Medical Director for Pediatric Specialty Care to join our well-established group.Packard Medical Group ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Sr. Manager Medical Writing

    Sr. Manager Medical Writing

    Beacon Hill • San Francisco, CA, United States
    [job_card.full_time]
    We are seeking a highly motivated, well-organized, and skilled Senior Manager of Medical Writing to develop clinical and regulatory documents in collaboration with internal and external stakeholder...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Statistics (Office based)

    Associate Director, Statistics (Office based)

    San Francisco Staffing • South San Francisco, CA, United States
    [job_card.full_time]
    Job Title : Associate Director, Statistics - Oncology.AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical ch...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Medical Director / Medical Director, Endocrinology / Metabolism Redwood City, California,[...]

    Associate Medical Director / Medical Director, Endocrinology / Metabolism Redwood City, California,[...]

    Corcept Therapeutics Inc • Redwood City, CA, United States
    [job_card.full_time]
    Associate Medical Director / Medical Director, Endocrinology / Metabolism.Redwood City, California, United States.Corcept is leading the way in the research and development of cortisol modulators, mole...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Clinical Data Analytics and Reporting

    Associate Director, Clinical Data Analytics and Reporting

    Eikon Therapeutics • Millbrae, CA, United States
    [job_card.full_time]
    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for lif...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director, Medical Affairs Content and Training

    Associate Director, Medical Affairs Content and Training

    Revolution Medicines • Redwood City, CA, United States
    [job_card.full_time]
    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s RAS(ON) Inhibito...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Clinical Data Management

    Associate Director, Clinical Data Management

    Vaxcyte • San Carlos, CA, United States
    [job_card.temporary]
    Join our Mission to Protect Humankind!.Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, wh...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Regulatory (Medical Writing) Scientific Communications Director

    Associate Regulatory (Medical Writing) Scientific Communications Director

    Exelixis • Alameda, CA, United States
    [job_card.full_time]
    Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Medical Writing

    Director, Medical Writing

    Septerna • San Francisco, CA, United States
    [job_card.full_time]
    Be among the first 25 applicants.Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the indu...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Medical Director

    Associate Medical Director

    Katalyst CRO • San Francisco, CA, United States
    [job_card.full_time]
    With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams t...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Medical Communications

    Associate Director, Medical Communications

    Cytokinetics • South San Francisco, CA, United States
    [job_card.full_time]
    Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Medical Director - Enablement, Education, and Outcomes

    Medical Director - Enablement, Education, and Outcomes

    Regard • San Francisco, California, US
    [job_card.full_time]
    Job Description Job Description We're seeking a Medical Director to accelerate adoption and support growth across our customers and prospective partners. Reporting directly to the Chief Medical Of...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]