UNKNOWN

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The primary function of a Regulatory Project Manager, Clinical Evaluations ("Clinical Evaluation Report (CER) Project Manager (PM)") is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, A&P and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).

YEAR

Abbott Laboratories

Senior Project Manager, Clinical Evaluation

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The primary function of a Regulatory Project Manager, Clinical Evaluations (“Clinical Evaluation Report (CER) Project Manager (PM)”) is to combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, A&P and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).

At Abbott, we are enthusiastic, energetic and committed to doing great work every day. Our employees are passionate about helping to translate science into lasting contributions to health care and the health of people worldwide. At the heart of our organization is our "Promise for Life"&mdash;a statement that embodies our company's commitment to employees, shareholders, local communities and the people who depend on our company and products to live healthier lives.
 
Vital to our promise is the speed in which we act, respond and deliver. As Abbott employees, we are ready to meet change and challenges head-on. As a result, we are a company that adapts quickly, and through our passion for innovation we are able to continually create a pipeline of products that help improve the length and quality of life around the world.
 
We are proud of our rich, more than 120-year history. We continue to be driven to advance leading-edge science and technologies, support diversity, focus on exceptional performance and earn the trust of those we serve.

Abbott

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Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator's Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials. Calico's highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

California Life Company

Associate Director, Medical Writing

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Must have strong analytical and critical thinking skills, strong attention to detail, ability to interpret and clearly present clinical data and other complex information, and an internal drive to produce clear and thorough, accurate, and high-quality documents. Collaborate with cross-functional teams, including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and biostatistics to ensure development of high-quality accurate documents delivered within project timelines.

Zentalis Pharmaceuticals Inc

Associate Director Medical Writing

Collaborate with Clinical development teams including Clinical Operations, Regulatory, Clinical Data Management, and Biometrics/Stats to advance data acquisition and analyses of clinical trial data. Collaborate with Translational Medicine, Bioinformatics, and Statistical teams for exploratory biomarker correlative studies and deeper analysis of tumor biology and CAR T functionality.

HOUR

Pyramid Consulting, Inc

Research Scientist Multiple Myeloma / Translational Medicine

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Support short- and long-term communications planning by developing key assets, managing complex project schedules, tracking resources and coordinating work across teams for large-scale production jobs, often collaborating with editors, designers, photographers and web strategists. This position will lead communications for LLNL's Laboratory Directed Research and Development (LDRD) program and Academic Engagement Office (AEO), bringing to life the bold ideas, pioneering research and scientific talent driving the Laboratory's national security mission.

Lawrence Livermore National Laboratory

Communications Specialist

Provide accurate, balanced, evidence-based, and timely responses to unsolicited medical and scientific inquiries from healthcare professionals, patients or caregivers, and internal colleagues, using approved response documents, current literature, and appropriate data on file. A key focus of the role will be supporting Medical Information readiness for the upcoming multiple myeloma launch, including development of scientific response resources, management of anticipated inquiry topics, and preparation of internal and external support teams.

Net2Source Inc. is a Global Workforce Management Solutions Company, headquartered in New Brunswick, NJ with its local offices in Texas, California, Florida, Illinois, Colorado and Michigan and its global operations in Canada, UK, Europe, UAE, Malaysia, Australia, China, Singapore and India. Net2Source offers a wide gamut of consulting solutions customized to specific client needs including but not limited to Application Development, Workforce Management and Project Consulting.

Whether it’s a Fortune client, whether it’s a System Implementer or whether it is a Start -up, our recipe to success – Exceed expectations! Under promise, over deliver.

NET2SOURCE INC

Associate Director, Medical Information

Regulatory filing experience and a demonstrated ability to facilitate clinical trial execution, synthesize scientific data, communicate key findings cross-functionally is required. Collaborates with Clinical development teams including Clinical Operations, Regulatory, Clinical Data Management and Biometrics/Stats to advance data acquisition and analyses of clinical trial data.

Research Scientist-Multiple Myeloma

Iconma LLC

Research Scientist, Multiple Myeloma - Translational Medicine

You'll partner closely with Product, Sales, Customer Experience, and Marketing to define go-to-market strategy, positioning, marke launches, and translate sophisticated capabilities into clear customer value. You do need the deep curiosity to ask questions, seek answers, learn a complex and impactful domain, and help define how technology changes the way scientific work gets done.

Benchling

Product Marketing Manager

Serve as the leader of cross-functional Publications Team(s) for assigned assets, including leading team meetings/discussions and driving the execution of publication plans, incorporating input from key global stakeholders. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

AbbVie Inc

Sr. Publication Manager- Neuroscience

Responsibilities: Serve as the leader of cross-functional Publications Team(s) for assigned assets, including leading team meetings/discussions and driving the execution of publication plans, incorporating input from key global stakeholders. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

Publications Manager- Immunology

FULL_TIME

Responsibilities: Serve as the leader of cross-functional Publications Team(s) for assigned assets, including leading team meetings/discussions and driving the execution of publication plans, incorporating input from key global stakeholders. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​.

AbbVie

Publications Manager- Neuroscience

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Serve as the leader of cross-functional Publications Team(s) for assigned assets, including leading team meetings/discussions and driving the execution of publication plans, incorporating input from key global stakeholders. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​.

Senior Manager, Publications- Immunology

Lead Publications Teams in the execution of publication plans for assigned assets, and oversee the execution of scientific publications (ie, clinical manuscripts, abstracts, posters, and oral presentations) that fulfill strategic publication plan and scientific communications objectives for the asset. Serve as the leader of cross-functional Publications Team(s) for assigned assets, including leading team meetings/discussions and driving the execution of publication plans, incorporating input from key global stakeholders.

Manager, Publications

AbbVie, Inc

Senior Manager, Publications

Senior Manager Publications- Immunology

Manager Publications

Benchling Inc

Interface with design engineers, test engineers, program management, maintenance technicians, technical writers, pilots, and other professional staff to coordinate operational or maintenance workarounds, improved procedures, software updates, or hardware modifications as required in response to field incidents and anomalies. Must possess the ability to understand new concepts quickly; apply them accurately throughout an evolving environment; organize, schedule, and coordinate work phases; and determine the appropriate approach at the task level or, with assistance, at the project level to provide solutions to a range of complex problems.

Scientific Writer Jobs in California

Senior Project Manager, Clinical Evaluation Abbott Laboratories

Senior Project Manager, Clinical Evaluation Abbott

Associate Director, Medical Writing California Life Company

Associate Director Medical Writing Zentalis Pharmaceuticals Inc

Research Scientist Multiple Myeloma / Translational Medicine Pyramid Consulting, Inc

Communications Specialist Lawrence Livermore National Laboratory

Associate Director, Medical Information NET2SOURCE INC

Research Scientist-Multiple Myeloma NET2SOURCE INC

Research Scientist, Multiple Myeloma - Translational Medicine Iconma LLC

Product Marketing Manager Benchling

Sr. Publication Manager- Neuroscience AbbVie Inc

Publications Manager- Immunology AbbVie Inc

Publications Manager- Neuroscience AbbVie

Senior Manager, Publications- Immunology AbbVie

Manager, Publications AbbVie

Senior Manager, Publications AbbVie, Inc

Senior Manager Publications- Immunology AbbVie Inc

Manager Publications AbbVie Inc

Product Marketing Manager Benchling Inc

Engineer II General Atomics

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