- Lead, build and manage cutting-edge Medical Information systems, SOPs and best practices to support the company's lead asset, AD109, pre- and post-launch
- Lead creation and maintenance of accurate and fair-balanced standard response letters (SRL) and custom responses to unsolicited external medical information requests
- Identify, select and manage high-performing partners and vendors to support compliant responses to unsolicited requests for medical information, as well as intake and triage of AE and PQC case reports
- Establish, track, and report KPIs for inquiry volume, turn-around times, and customer satisfaction
- Identify data gaps and contribute to generation of medical insights to support company and functional strategic planning
- Provide in-person medical information support at medical and scientific congresses, including booth-related activities and materials
- Lead development, updating, and distribution of AMCP or other payer-related dossiers
- Monitor and maintain bibliography of relevant scientific literature for company and disseminates new publications internally, in partnership with Medical Communications team
- Collaborate with Pharmacovigilance and Quality teams to design and execute intake and processing of AE and PQC case reports
- Supports MLR review process for internal and external medical and commercial materials
- Ensure best practices and full compliance with all regulatory, industry, and company requirements for medical information
- Provide scientific training to vendors and internal colleagues as needed
- Monitor industry trends and innovations and implement best practices to heighten efficiency, quality, and value of medical information.
- Doctoral degree in health sciences (PharmD, MD, PhD, DSc)
- Expert knowledge of North American and EU regulatory guidelines and requirements for medical information, adverse event and product complaint case reporting
- 7+ years of biopharmaceutical industry experience in medical affairs, primarily in medical information, ideally in both large and small companies
- Previous experience designing, building and implementing medical information systems, processes (including SOPs) and content to support one or more drug launches
- Demonstrated excellence in communication skills (written and oral) including the ability to clearly, concisely, and accurately summarize complex scientific data and medical literature
- Current and deep understanding of regulatory and industry guidances, policies, and processes (FDA, EMA, MHRA, phactMI) regarding medical information and promotional review
- Successful selection and management of high-performing MI/PV/QC call center and fulfillment vendors from RFP process through contracting, training, implementation, management, and reporting
- Experience developing and implementing a robust and compliant online medical information portal with self-service or chatbot functionality
- Working knowledge or experience with AI/ML in Medical Information
- Demonstrated ability to think strategically and execute with agility; able to "get the right things done well"
- Strong ability to "roll up one's sleeves" when necessary, and delegate when preferable
- Superb project management skills, designing and executing plans to meet timelines and budgets
- Keen ability to quickly and consistently build and maintain high levels of trust with internal and external colleagues
- Proven ability to build strong working relationships and collaborate effectively with internal and external colleagues
- Strong problem solving, risk mitigation and time management skills
- Unimpeached track record of the highest levels of integrity, honesty, and ethics
- Ability to travel, up to 20%, mainly in U.S.
- 401(k) with company match
- Generous time off for vacation
- Generous healthcare benefits
- Flexible working environment
- Motivated and experienced team
- Apnimed is a privately held company based in Cambridge, MA; we are generally virtual and specific location within the US is flexible.
- Must be able to travel as necessary.
- Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
- Please visit us at to learn more about our work with Obstructive Sleep Apnea
-
Director, Medical Information
3 weeks ago
Apnimed Cambridge, United StatesApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our ...
-
Partners HealthCare Boston, United States Full timeDescription The Opportunity · Healthcare has seen a renewed focus on both the patient and provider experience, and an expanding reliance on established and emerging digital technologies to deliver high quality, safe, equitable and efficient care. The MGB Associate CMIO will pr ...
-
Associate Director, Medical Information
2 weeks ago
Blueprint Medicines Cambridge, United StatesHow will your role help us transform hope into reality? · Reporting to Head of Global Medical Information, this newly created position is responsible for supporting the Medical Information Services (MIS) function at Blueprint Medicines. This person will play a significant role in ...
-
Medical Information Specialist
1 week ago
SSi People Bridgewater, United StatesAt least 2-3 years of direct medical information experience in a global setting in the pharmaceutical industry, or equivalent experience & background in a clinical setting. Medical Information fellowship/ residency is a plus. · Knowledge and skills as a medical writer, literature ...
-
argenx Boston, United States OTHERThe Senior Manager of Content Management will assist in the content creation efforts for the Global Medical Information function which will ensure timely and accurate responses are provided to unsolicited medical and clinical inquiries from healthcare professionals, patients, cli ...
-
South Shore Health Norwell, United StatesJob Description Summary · Respond to requests for protected health information from patients, physicians, insurance companies, attorneys and other requestors. · Ensure that such information is disclosed in accordance with applicable State and Federal statutes. · Job Description ...
-
Health Information Svs Manager
3 weeks ago
Harvard University Cambridge, United States**Job Summary** · Under the direction of the Director of Health Information Services (HIS) / Privacy Officer, the HIS Manager is responsible for the direct oversight of the medical record department's operation to ensure accurate and reliable patient information management that c ...
-
Registered Nurse
3 weeks ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · RegularScheduled Hours: · 40Work Shift: ...
-
Medical Receptionist
3 weeks ago
West Cambridge Pediatric & Adolescent Medicine Cambridge, United States**West Cambridge Pediatric and Adolescent Medicine is a large size practice and is looking for a friendly, outgoing front desk staff member who can multitask in a fast-paced environment.** · ***: · **The medical receptionist is responsible for greeting and checking in all patient ...
-
Medical Assistant
1 week ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Location: · 480 Pleasant Street · Watertown, MA · ...
-
Urology Medical Assistant
5 days ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · The Medical Assistant provides high quality, direct ...
-
Medical Assistant
3 weeks ago
Ancestor Health Cambridge, United States**Job Type**: Full Time · Job Category: Nursing · Job Title: Medical Assistant (Nursing) · Job Summary: · Responsibilities and Duties: · - Assist healthcare providers with patient examinations and procedures · - Take vital signs, record patient information, and update medical rec ...
-
Registered Nurse
4 days ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Night (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Registered Nurse - Stanton 3Job Description: · Pr ...
-
Registered Nurse
1 week ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Registered Nurse - GI UnitJob Description: · Primar ...
-
registered nurse
3 weeks ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Rotating (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · RegularScheduled Hours: · 36Work S ...
-
Vice President, Clinical Development
2 weeks ago
Bicycle Therapeutics Cambridge, United States**Company Description** · Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA. · **Culture** is key and all Bicycle employees actively embrace and role model our company values: · - We are **A ...
-
Registered Nurse, Emergency Department
3 weeks ago
Bilkins Cambridge, United States_**Job summary **:_**BILKINS** is seeking a **" Registered Nurse - Emergency Department (Travel)" Position for Cambridge, Massachusetts **Please feel free to contact me on ** · **if you have any questions or concerns. · **Job detail**: · - **Position**_**:_**Registered Nurse - M ...
-
Administrative Aide
3 weeks ago
State of Maryland Cambridge, United States**Introduction**: · **GRADE**: · ASTD11 · **LOCATION OF POSITION**: · MDH, Eastern Shore Hospital Center, Cambridge, MD (Dorchester) · **Main Purpose of Job**: · The main purpose of this position is to provide administrative support and date master to the Activity Therapy Manager ...
-
Personnel Associate Iii
3 weeks ago
State of Maryland Cambridge, United States Full time**Introduction**: · **GRADE**: · ASTD12 · **LOCATION OF POSITION**: · MDH - Eastern Shore Hospital Center 5262 Woods Road, Cambridge, MD. (Dorchester) · **Main Purpose of Job**: · - This full time contractual position has primary responsibility for reconciling timekeeping to payr ...
-
Registered Nurse
2 weeks ago
Mount Auburn Hospital Cambridge, United States Full timeJob Type: Regular · Time Type: Full time · Work Shift: Rotating (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Registered Nurse - Emergency Room Residency Pr ...
Director, Medical Information - Cambridge, United States - Apnimed
Description
Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.
The Director, Medical Information, will be responsible for leading, building and managing a world-class Medical Information function to support the launch of Apnimed's lead compound, AD109 and the pipeline to follow. The ideal candidate will be a true medical "triple threat" demonstrating high levels of scientific excellence, business acumen, and emotional intelligence.
This leader will report to the Vice President, Medical Affairs, and may be based in Apnimed headquarters in Cambridge, Massachusetts, or based remotely with travel to the home office as needed.
Key Job Duties include, but are not limited to:
Education:
Work-related Skills & Experience
What Apnimed Offers:
Location and Other Information:
