Associate Director, Medical Writing - Newark, CA | Biospace
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Associate Director, Medical Writing

Depomed, Inc.

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Location:
Newark, CA
Posted Date:
12/10/2016
Position Type:
Full time
Job Code:
783XX
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

City Newark
State California [CA]
Title Associate Director, Medical Writing
Job ID 783XX
Date Added 11/9/2016
Department Clinical Affairs

Description

JOB SUMMARY
The Associate Director Medical Writing in Clinical Affairs will be the lead on medical writing projects pertaining to clinical drug development programs in CNS. Responsibilities include deliverables such as clinical study documents and related submissions to regulatory authorities. This position will report to the Vice President Clinical Affairs.

ESSENTIAL JOB FUNCTIONS
• Manages planning and preparation of clinical and regulatory documents which include but are not limited to clinical study protocols, clinical study reports, investigator brochures, briefing books, integrated summaries, IND sections and other regulatory submission documents
• Coordinates the cross-functional review of clinical and regulatory documents
• Develops and manages timelines for the delivery of clinical and regulatory documents
• Provides high-quality deliverables in compliance with regulatory requirements and internal SOPs
• Responsible for consistent style guide, templates and formats of clinical and regulatory documents
• Provides oversight to medical writing resources at vendors and CROs
• Responsible for medical writing project budgets
• Represents medical writing on cross-functional teams
• Supports the document management system

ADDITIONAL RESPONSIBILITIES/DUTIES
• Develops strong internal relationships within the R&D organization
• Keeps abreast of regulations and developments in medical writing and maintains relevant knowledge of the therapeutic area

Requirements

EDUCATION AND EXPERIENCE
• MS, PhD, PharmD or MD degree
• Minimum of 7 years relevant clinical development medical writing experience in pharmaceutical, biotech or CRO positions
• Knowledge of ICH, GCP and relevant regulatory guidelines
• Experience in CNS and/or pain therapy preferred
SKILLS AND ABILITIES
• Excellent writing, communication, project management, interpersonal skills
• Excellent ability to interpret and present scientific, clinical and statistical data
• Demonstrated ability to work on several projects at once while balancing multiple and overlapping timelines
• Demonstrated abilities in both collaboration with others and independent work
• Computer proficiency in Microsoft Office, Microsoft Visio and Adobe Acrobat required

DEPOMED COMPETENCIES INCLUDE
• Therapeutic Area Knowledge
• Leadership
• Flexibility
• Strategic Thinking
• Networking
• Relationship Building
• Influence

PHYSICAL/MENTAL DEMANDS
• Sitting: 90%
• Standing and Walking: 10%
• Able to communicate with individuals utilizing a phone requiring ability to hear and speak effectively

About Us

Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. Founded in 1995, Depomed has successfully executed on strategy of acquiring, integrating and growing differentiated therapeutic products and building each into a strong market presence. The result is a broad portfolio of pain and neurology specialty pharmaceuticals currently comprised of five FDA-approved products. These include Gralise® for the management of Postherpetic Neuralgia (PHN), Cambia® for the acute treatment of migraine attacks, Zipsor® for the relief of mild to moderate acute pain, Lazanda® for the management of breakthrough pain in cancer patients and our most recent addition, the company’s flagship asset, the NUCYNTA® franchise.

Acquired in April 2015 and re-launched in June 2015, the NUCYNTA franchise includes NUCYNTA® ER for the extended management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN) and NUCYNTA® for immediate management of moderate to severe acute pain in adults.


Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract. The company’s Acuform technology is currently being used in four marketed drugs, including Gralise.

Depomed’s successful execution on strategy and has resulted in solid product revenue growth over the past three years. Located in Newark, California in the East Bay of San Francisco, Depomed is listed on the NASDAQ market under the ticker DEPO and employs approximately 500 people, of which approximately 350 are part of the Commercial organization.


Depomed is an AA/EEO/Veterans/Disabled employer.