Sr Specialist Medical Legal Review Alexion Pharmaceuticalsinc Salary

Chore Description:

Alexion Pharmaceuticals, Inc.

Alexion is an Equal Opportunity/Affirmative Action Employer.

Attention: If you are a electric current Alexion employee, please apply via Alexion'due south internal Life & Career portal. . Annotation that you lot will demand to be continued to the VPN if you are applying away from the part. Alexion does not contact candidates via instant messaging or conversation tools. At no time will we ask candidates for fees associated with obtaining software, nor practice nosotros provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, delight be aware that it is fraudulent, and please practice not provide whatsoever information or money to these individuals. Applicants should only employ through this Alexion website. Whatsoever fraudulent activity should exist reported to GSOC@alexion.com

Req ID: 28217
Job Category: Global Medical Affairs
Location: Boston, MA
Posting Date: Apr 15, 2022
Some opportunities happen only once in a lifetime - like a job where you take the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their all-time lives. We value the uniqueness and diversity of our employees and recognize that nurturing the various perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Sr Manager of Global Medical Information and Medical Review leads the evolution and transfer of intellectual capital that maximizes the safe and appropriate use of Alexion products to healthcare professionals and patients world-wide. This person is accountable for leading therapeutic expanse team(s), developing functional strategies, establishing objectives and priorities, and overseeing the execution of global medical data and medical review activities for assigned therapeutic area(s). This includes strategizing and adjustment global medical data pre- and post-launch plans with internal constituents in Global Medical Diplomacy, Global and Local Commercial Teams, and Global Clinical Development Teams. The Sr Director is accountable for advancing the team's value through collaboration and implementing cadre processes and systems/technologies, enhancing operations and infrastructure and ensuring responsible fiscal execution to support the development and dissemination of medical information globally.

In addition, the Sr Director volition provide essential oversight in the review and delivery of high quality promotional and medical materials, internal sales training materials, and presentations / communications equally role of the Medical/Legal/Regulatory (MLR) Review Committee.

The employee carries out this role in accord with departmental SOPs, corporate policy and other legal and regulatory requirements.

Direct Reports: Directors, Acquaintance Directors and Sr / Managers in Global Medical Information and Medical Review.

You volition be responsible for:

• Leading therapeutic area (TA) squad(due south) and operations by developing functional strategies, establishing objectives and priorities, and overseeing the execution of global medical information and medical review activities.
• Leading (edifice as necessary) a high-performance medical information / medical review team to support assigned therapeutic areas. Manage, train and mentor Associate Directors, Managers, Fellows and third-party contact center team to ensure alignment with operational objectives, excellence in execution, and maintenance of quality functioning. Provide mentorship to directly reports to support their professional person and personal development.
• Serving equally a change agent and promoting the value suggestion of TA team and department to cross functional stakeholders.
• Providing strategic planning, prioritization, and execution in alignment with internal stakeholders (Global Medical Affairs, Global and Local Commercial, Global Clinical Development) to ensure product launch preparedness in the global dissemination of medical information.
• Establishing annual operating plan for team/function and beingness accountable for financial oversight/adherence
• Developing / maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
• Overseeing the development, review and blessing of medically accurate, up-to-date, and timely intellectual uppercase (e.m., medical information response documents, ofttimes asked questions, slide decks) addressing the global scientific community'southward noesis gaps in disease / diagnosis, product data and clinical information in order to ensure consistency in scientific exchange past US and world-wide Medical Affairs personnel in a compliant style.
• Every bit a member of the Global Medical Affairs Team (GMAT), contributing to the evolution and implementation of the Brand Medical Plan.
• As applicable, representing medical function in the MLR Review Committee and ensures scientific / medical / clinical accuracy, relevance and completeness of data and that promotional claims inside materials are adequately supported past data.
• Understands, finer applies and ensures team complies with advisable ethical, legal and regulatory standards, including those for product promotion and for responding to unsolicited requests for on/off label inquiries.
• Ensures compliance with internal inspect and Health Authority / regulatory document requirements.

Yous will need to take:

• Advanced scientific degree in chemist's shop (PharmD) or related science (PhD, Physician) with x+ years of medical information or medical communications experience in the pharmaceutical / biotech manufacture
• 5 years of formal management experience
• iii years of experience in reviewing promotional materials
• Demonstrated proficiency in strategic-thinking and exercising operational excellence
• Strong collaboration and influential skills
• Thorough knowledge of the regulatory and compliance requirements / limitations applicable to medical data, as well as promotional and non-promotional pharmaceutical materials
• Experience leading medical information or medical communication initiatives for a production launch
• Experience in developing work practice documents, SOPs and effective grooming materials
• Excellent written and verbal communication skills
• Strong skills in project planning, courageous/challenging conclusion-making, problem-solving, and negotiating towards mutually beneficial outcomes
• Highly proficient with Microsoft Office Suite
• Ability to travel to meetings / conferences (including internationally) approximately 20% of the time
• The duties of this role are generally conducted in an part environment. As is typical of an office-based role, employees must exist able, with or without an accommodation to: use a estimator; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought analysis, and dialogue; interact with others; maintain full general availability during standard business hours.

Nosotros would prefer for you to have:

• Demonstrated success in leading teams through transformation and delivery of new operating models
• Experience providing medical information/medical communication support within a Global function
• 5 years of relevant experience in review/editing promotional materials
• v years of formal direction experience
• Feel developing (or overseeing the development of) materials utilized by Medical Affairs in the context of scientific exchange
• Training or past experience in assigned therapeutic area(southward) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies
• Feel managing majuscule and operational budgets

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Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating weather through the discovery, evolution and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices effectually the world and serves patients in more than than 50 countries. Furtherinformation near Alexion can be found at: www.alexion.com .

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a civilisation of belonging where every single person tin belong because of their uniqueness. The Company will non make decisions virtually employment, training, bounty, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sexual activity, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital condition,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental condition (including adoption or surrogacy), armed services status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-xix and its variants. All U.s.a.-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law likewise equally reasonable accommodations to come across the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding a legally required exemption or adaptation, please contact accommodations@Alexion.com . Alexion participates in E-Verify.

As a leading employer in our manufacture, Alexion offers a highly competitive package of base of operations and incentive compensation besides every bit a comprehensive benefits program designed to back up the health, health and financial security of our employees and their families. Benefits include grouping medical, vision and dental coverage, group and supplemental life insurance, 401(k) with visitor lucifer, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marker the cosmos of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click hither .

Alexion participates in East-Verify process. To learn more, please click on fastened document(s)PI174092496

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