Director, Medical Writing San Francisco, CA/Hybrid

Found in: Jooble US O C2 - 3 weeks ago

San Francisco CA, United States BridgeBio Pharma Full time

Calcilytix Therapeutics , an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluatedinaPhase 3clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

This experienced Medical Writer will lead medical writing activities associated with the planning, development, and finalization of high-quality clinical and regulatory documentation. This individual is the responsible subject-matter expert in the field of medical writing and will function as an individual contributor while providing oversight of contract medical writers. The successful candidate is expected to develop strong relationships with various departments and with different levels of management, including interactions across BridgeBio subsidiaries. The scope ranges from early clinical development through submission and maintenance of license applications.

Responsibilities
  • Lead medical writing process for new protocols/synopses, protocol amendments, clinical study reports, investigator brochures, and related regulatory documents
  • Align cross-functionally to set strategies and goals for the management of internal and external medical writing resources to meet corporate goals and team objectives
  • Ensure company templates and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines)
  • Maintain a company style guide that includes standard language for regulatory documents
  • Partner with clinical development, biostatistics and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning
  • Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
  • Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately archived in agreed document management system
  • Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements
  • Suggest or identify modifications and improvements to document preparation processes and company templates in order to improve quality, efficiency, and productivity

No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills Requirements
  • At least a Bachelor of Science or equivalent degree, post-graduate degree preferred
  • Successful experience leading medical writing activities for multiple regulatory filings at various development stages
  • Excellent oral and written communication skills with an ability to summarize complex raw data in a concise, accurate and easily understandable form
  • Thorough knowledge of clinical research, health authority regulations, ICH Guidelines and medical writing standards with ability to interpret and apply these to document writing
  • Excellent interpersonal, active listening, and influencing skills
  • Strong leadership and project management skills, ability to work independently, multi-task, and work effectively under pressure
What We Offer
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. #J-18808-Ljbffr

  • Audiologist - San Francisco, Ca

    7 days ago

    San Francisco, United States BASS MEDICAL GROUP Full time

    We are currently looking for an **audiologist** to join our ENT practice, partnered with BASS Medical Group, in **San Francisco, CA**. - Outstanding opportunity to join our well-established ENT practice and work alongside 7 otolaryngologists, 1 audiologist, 1 audiology tech, and a tenured support staff - Our practice provides the full scope of evidence-based...

  • Addiction Medicine

    Found in: beBee S US - 3 weeks ago

    San Francisco, United States San Francisco Department of Public Health Full time

    Working under the Medical Director to protect and promote the health of all San Franciscans. San Francisco Department of Public Health strives to achieve its mission through the work of two main Divisions - the San Francisco Health Network and Population Health. ​ Each facility within SFDPH supports a unique population and need within the...

  • Assistant Director Of Admissions

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States San Francisco Film School Full time

    The San Francisco Film School is on the lookout for an experienced, results oriented, high-energy Assistant Director of Admissions to join our dynamic team of professionals. You should be data driven, have top-notch customer service skills, be passionate about changing people’s lives, and demonstrate the ability “to close”. Our ideal applicant is a...

  • Director of Staff Development

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States San Francisco Health Care and Rehab Full time

    Job Description Job Description We are searching for a Director of Staff Development to join our team! POSITION SUMMARY: The primary purpose of this position is to lead and manage staff development process using available resources to ensure facility staff are competent, qualified, and function within legal, regulatory and company business objectives. ...

  • Municipal Associate

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States The San Mateo County Bar Association Full time

    We are Renne Public Law Group (RPLG), recently named by the Daily Journal as one of the Top 20 Boutique Law Firms in California. Two of our partners are Daily Journal Top 100 Women Lawyers in California, and other partners are California Super Lawyers. RPLG seeks an associate with 1-6 years of municipal law advisory experience to provide advice to local...

  • Full time Faculty Medical Director

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States The University Of Tennessee Health Science Center Full time

    Full time Faculty Medical Director – University of California San Francisco The UCSF Zuckerberg San Francisco General Hospital (ZSFG) Department of Psychiatry and Behavioral Sciences (DPBS), Division of Substance Abuse and Addiction Medicine is inviting applications for a board certified or board eligible addiction psychiatrist / addiction medicine...

  • Threat Intelligence Specialist

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States Peacefestival Full time

    Opportunities for Threat Intelligence Specialist – San Francisco in San Francisco, CA Remote positions only Search completed. Found 0 matching records. Opportunities for Threat Intelligence Specialist – San Francisco in San Francisco, CA Remote positions only Search completed. Found 0 matching records. Threat Intelligence Specialist - San...

  • Aquatics Director II

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States YMCA of San Francisco Full time

    Imagine going to work knowing that what you do each day positively influences the lives of people and communities. As the nation's leading nonprofit organization committed to strengthening communities through youth development, healthy living and social responsibility, the YMCA of San Francisco offers more than just a job--we offer you a career with a...

  • Gastroenterologist - Locums - San Francisco, CA

    Found in: Lensa US P 2 C2 - 2 hours ago

    San Francisco, United States MPLT Healthcare Full time

    Gastroenterologist Location: San Francisco, CA MPLT Healthcare is looking for physicians who Understand the Urgency, Never Give Up, and Have the Courage to Excel in the forever changing medical industry! We have numerous opportunities for an experienced Gastroenterologist with highly competitive pay rates in San Francisco, CA. Position Details: ...

  • Assistant Sales Director Of Admissions

    2 weeks ago

    San Francisco, United States San Francisco Film School Full time

    Job DescriptionJob DescriptionThe San Francisco Film School is on the lookout for an experienced, results-oriented, high-energy Assistant Sales Director of Admissions to join our dynamic team of professionals. You should be data-driven, have top-notch customer service skills, be passionate about changing people’s lives, and demonstrate the ability “to...

  • Operations Coordinator

    3 days ago

    San Francisco, United States BAMO Full time

    Operations Coordinator (San Francisco, CA) The Office Coordinator will work directly with the Culture Manager and the Director of Operations to assist the management and contribute to the success of a performance-driven environment. Duties include but are not limited to facilities management, calendar and email management, file and database management, light...

  • Operations Coordinator

    2 days ago

    San Francisco, United States BAMO Full time

    Operations Coordinator (San Francisco, CA) The Office Coordinator will work directly with the Culture Manager and the Director of Operations to assist the management and contribute to the success of a performance-driven environment. Duties include but are not limited to facilities management, calendar and email management, file and database management, light...

  • Associate Director of Clinical Inclusion

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States YMCA of San Francisco Full time

    Associate Director of Clinical Inclusion Mental Health Services Executive Director Salary range: $82,624 to $90,000 per year Careers with a Cause Imagine going to work knowing that what you do each day positively influences the lives of people and communities. As the nation's leading nonprofit organization committed to strengthening communities...

  • Pulmonary and Critical Care in San Francisco

    Found in: beBee S US - 2 weeks ago

    San Francisco, United States San Francisco Lung & Sleep Full time

    Pulmonary / Critical Care / Sleep practice in downtown San Francisco seeking additional physician to join our group of 12. Work in a quaternary-care teaching hospital with housestaff and nurse practitioners on ICU services, and ample outpatient opportunity. Collegial work environment, 2-year partnership track, full benefits, and $330k starting salary. If...

  • Internal Medicine

    Found in: beBee S US - 3 weeks ago

    San Francisco, United States Sutter West Bay Medical Group Full time

    Sutter West Bay Medical Group has an opportunity for an Internal Medicine Physician to join a premier, an innovative, and rapidly growing group of providers. Our clinics are located in six dynamic San Francisco neighborhoods and provide all the advantages of a community-based private practice with the added support of a larger, multispecialty organization....

  • Family Medicine

    Found in: beBee S US - 3 weeks ago

    San Francisco, United States Sutter West Bay Medical Group Full time

    Sutter West Bay Medical Group has an opportunity for a Family Medicine Physician to join a premier, innovative, and rapidly growing group of providers. Our clinics are located in six dynamic San Francisco neighborhoods and provide all the advantages of a community-based private practice with the added support of a larger, multispecialty organization. Work in...

  • Litigation Associate Attorney

    Found in: Jooble US O C2 - 3 weeks ago

    San Francisco, CA, United States The San Mateo County Bar Association Full time

    The San Francisco office of Perkins Coie LLP is seeking an associate to join its Commercial Litigation group. Candidates must have excellent academic credentials, a JD from a top-tier law school and at least 3-5 years of complex litigation experience at an AmLaw 100 law firm. Preference will be given to candidates with broad litigation experience, including...

  • Pulmonary and Critical Care in San Francisco

    Found in: Talent US C2 - 2 weeks ago

    San Francisco, United States San Francisco Lung & Sleep Full time

    Pulmonary / Critical Care / Sleep practice in downtown San Francisco seeking additional physician to join our group of 12. Work in a quaternary-care teaching hospital with housestaff and nurse practitioners on ICU services, and ample outpatient opportunity. Collegial work environment, 2-year partnership track, full benefits, and $330k starting salary. If...

  • Associate Program Director

    Found in: Jooble US O C2 - 2 weeks ago

    San Francisco, CA, United States YMCA of San Francisco Full time

    Imagine going to work knowing that what you do each day positively influences the lives of people and communities. As the nation's leading nonprofit organization committed to strengthening communities through youth development, healthy living and social responsibility, the YMCA of San Francisco offers more than just a job--we offer you a career with a...

  • Aquatics Director II

    2 weeks ago

    San Francisco, United States YMCA of San Francisco Full time

    Imagine going to work knowing that what you do each day positively influences the lives of people and communities. As the nation's leading nonprofit organization committed to strengthening communities through youth development, healthy living and social responsibility, the YMCA of San Francisco offers more than just a job--we offer you a career with a future...